regulatory affairs specialist jobs
A Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. You can apply the above job description example as a template to effectively describe the available regulatory affairs specialist role in your organization, which will increase your chances of getting the right persons for the job. WebSearch, find and apply to job opportunities at Stryker, one of the worlds leading medical technology companies. Software, (This will open in a new window from which you will be automatically redirected to an external site after 5 seconds), https://www.hr.upenn.edu/PennHR/benefits-pay, https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Regulatory-Affairs-Specialist--Remote-Eligible--Abramson-Cancer-Center-_JR00067798. In terms of academic qualifications, the position of a regulatory affairs specialist requires the ideal candidate to possess sound and adequate educational background, as he/she is required to possess a Bachelors degree in fields such as Biochemistry, Biological Sciences, Chemistry, Pharmacy, Toxicology, Medicine, Pharmacology, or Engineering. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. See our, Options: 1330, 1717, 2343, 262, 2375, 2201, ICON Full Service & Global Business Services, Early Clinical and Bioanalytical Solutions, Regulatory Affairs/ Drug Safety/ Quality Assurance. Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review. What You Will DoAs the Staff Regulatory Affairs Specialist, you will be Regulatory Lead for the General Surgery portfolio on new product development teams within the Endoscopy Business. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. No matter what part of ICON you work in, you are contributing to solving some of the most complex healthcare challenges and are helping to deliver new medicines and devices that are impacting millions of peoples lives, right across the world. Prepare complex regulatory submissions and/or presentations (i.e. Sign in to create your job alert for Regulatory Affairs Specialist jobs in United States. Our services span the entire lifecycle of product development and can be adapted to suit small local trials or large global programs. europe@pac.org, Certificate in PAC & Grassroots Management, Certificate in Government Relations and Lobbying, Virtual Workshop: Using Video for PAC and Grassroots Engagement, Virtual Workshop: Ethical Public Affairs in Government Relations, Hogans Fellowship Looks to Build Executive Pipeline, The Hogans Fellows In Their Own Words, Election Impact: Dont Give Up on The Media. They are often responsible for executing several important duties as a result of continuous and constantly evolving regulations worldwide. Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either changes in the business or regulatory requirements. 1000 Brussels Specialist Regulatory Affairs Specialist Jobs As a Regulatory Affairs Specialist you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. ORA is the lead office for all agency field activities. When you make products that can affect peoples lives and health, you must make certain youre operating within regulatory guidelines. Dedicated achievers. Regulatory Affairs Specialist - FDA Submissions, Regulatory Affairs Specialist / Senior Specialist, SR. Regulatory Affairs Specialist - HYBRID, Specialist, Regulatory Affairs, Human Factors, See who Mindlance has hired for this role. Piper Clinical Solutions is currently seeking a Regulatory Affairs Specialist to support a Clinical Research Organization (CRO)in the area of Bethesda, MD. This role is a senior member of the Regulatory staff, providing Regulatory expertise to cross-functional team members and mentoring junior Regulatory specialists. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate. Regulatory Affairs Specialist Never give out personal financial information. Learn more about jobs at Stryker. We encourage multilingual candidates to apply for our mission critical positions. WebAs the Specialist, Regulatory Affairs, you will support the execution of RA functions for both new product development and sustaining for assigned product line in critical care. Read the job description and highlight on your CV those experiences that we should learn about. Senior Regulatory Affairs Specialist Job Leesburg Virginia USA With our Government and Public Sector Solutions (GPHS) team you could be on the ground helping to resolve a crisis or having an impact on global health issues. Good knowledge in clinical trials documents and experience with CRF data entry. ICON offers a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. worldwide. Leverage your professional network, and get hired. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems. What would it look like to wake up every day feeling happy and fulfilled? Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies. General understanding of regulations applicable to the conduct of clinical trials. A Bachelors degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or Pharmacology. Suzaita's story - an insight into working in Clinical Research, Building DIB into the fabric of our organizational culture. Find job postings in CA, NY, NYC, NJ, TX, FL, MI, OH, IL, PA, GA, MA, WA, UT, CO, AZ, SF Bay Area, LA County, USA, UAE, SA, North America, abroad. Remember: this is our first time meeting you. You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. Good presentation skills. regulatory affairs jobs Sort by: relevance - date 335 jobs Regulatory affairs specialist new Statistical Pharma Remote in Pune, From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech. WebAs a Regulatory Affairs Specialist you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Job specializations: Completes and maintains regulatory approvals and clearances of assigned products. Participate in internal audit program. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. You Don't worry, we can still help! Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting. He/she also has to strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs. Listed on 2023-06-01. Web76 Regulatory Affairs Specialist jobs available in California on Indeed.com. Apply to Regulatory Specialist, Regulatory Affairs Manager, Director of Regulatory Affairs and more! Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. Cambridge, United Kingdom. Specialist Suggestions may be selected). Degree Requirements BS/BA in a relevant scientific or technical field preferred. Web19 results Regulatory Affairs Associate KSA (Hybrid) Riyadh, Riyadh Region Regulatory Affairs Intern (Onsite CAN Mississauga - Hybrid) Mississauga, Ontario Alternance - Affaires Rglementaires (H/F) Eybens, Auvergne-Rhne-Alpes Regulatory Affairs Intern (Onsite) Covington, Georgia BDB RA Specialist - Project Curie Regulatory Affairs Specialist You will collaborate with cross-functional teams, including research and development, clinical operations, Develop and execute global regulatory strategy for new and/or modified medical devices including for expanded indications for use. you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Don't worry, we can still help! Job Tittle: Regulatory Affair Specialist Location: 13330 Maycrest Way, Richmond, B.C, V6V 2J7 WebAs a Regulatory Affairs Specialist you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Web646 Regulatory Affairs Specialist jobs available on Indeed.com. We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles. Collaborative partners. Job Description: GDITs Military Health team is hiring a Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA) under the DoD (Dept. A Bachelors Degree (B.S or B.A) required; a Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus preferred. Good time and project management skills with the ability to multi-task. Integer posuere erat a ante venenatis dapibus posuere velit aliquet. Before sharing sensitive information, make sure you're on a federal government site. WebRegulatory Affairs Specialist I job at Abbott Laboratories | Abbott Careers PLAN FOR SUCCESS CAREER OPPORTUNITIES Our business encompasses many different functions and capabilities, which allows you to explore careers in Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. Specialist, Regulatory Liaison, Regulatory Affairs Regulatory Affairs Specialist job WebJob details. - listing US Job Opportunities, Staffing Agencies, International / Overseas Employment. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. He/she is also expected to understand and be familiar with all aspects of product development, which may include clinical trials, research, manufacturing practices, regulations, and approval processes. It is mandatory to procure user consent prior to running these cookies on your website. Abbott Regulatory Affairs Jobs | Apply Now Meticulous documenters. Are you a fit? They may also work in the government or law. Get notified about new Regulatory Affairs Specialist jobs in United States. We encourage our people to seize the opportunity to bring flexibility, innovation and determination to every situation. Subscribe to jobs like this! You can unsubscribe from these emails at any time. Jobs. With headquarters in Dublin, Ireland, ICON has employees in 119 locations across 53 countries. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable ICON systems. WebAs the Specialist, Regulatory Affairs, you will support the execution of RA functions for both new product development and sustaining for assigned product line in critical care. 2121 K St. Job specializations: Post pharmaceutical jobs for free; apply online for Science / Senior Regulatory Affairs Specialist job Virginia, USA. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information. Remote Regulatory Affairs Jobs Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone. WebAs a Regulatory Affairs Specialist you will be joining the world s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.More information is available at stryker.comR492272, Learn about Council Membership Early talent programs are designed to provide participants with opportunities to gain valuable experience, develop their skills, and build relationships with experienced leaders within the organization. Ensuring that IP labels are in adherence to country requirements and submitted where applicable. You will develop complex regulatory strategies and advise product development teams on regulatory implications of design, as well as assess design changes for impact to current regulatory status. Senior Regulatory Affairs Specialist Job Harrisonburg Virginia CMC Regulatory Affairs Specialist job with Regeneron A role as a Clinical Research Associate can be fast-paced, challenging and incredibly rewarding. Job Description. In addition to executing its mission through its federal workforce, ORA also works with its state, local, tribal, territorial and foreign counterparts to further the agencys mission. More information is available at www.stryker.comWe are currently seekinga Staff Regulatory Affairs Specialistto join ourEndoscopy Divisionbased in San Jose, CA or remotely anywhere within the United States.Who We Want. Staff Regulatory Affairs Specialist - Public Affairs Council The primary goal of this site is to highlight open FDA positions, share important tips for becoming a hireable candidate, information about our various centers, and insights into what working at FDA looks like for various employees. WebResponsibilities for the Regulatory Affairs Specialist: Prepare regulatory documentation, track regulatory activities, and ensure accuracy. Our Value:With a focus on understanding the needs and objectives of each enterprise we serve, Piper augments its staffing solutions with program management innovations to help teams reach maximum performance and deliver business results. As a (job title) you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Monday to Friday + 1. Job Description. - listing US Job Opportunities, Staffing Agencies, International / Overseas Employment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? WebApply JOB DETAILS LOCATION Bethesda, MD POSTED 1 day ago Piper Clinical Solutions is currently seeking a Regulatory Affairs Specialist to support a Clinical Research Organization (CRO) in the area of Bethesda, MD. Management of the central/country level Informed Consent and any other documentation given to patients i.e. Thats why we have developed additional learning opportunities & training programmes for continued growth in various career paths. I have spent the last 23 years on the executive leadership team of 3 different contract research organizations (CROs), and have been virtually the only person of color on all of them. JOB By doing this, our people build exciting and rewarding careers, deliver results to help bring life-changing medicines and devices to market and maintain ICONs success as an industry leader. Specialist This is a great place for regulatory professionals to apply their knowledge to, Recognized as great workplace in dozens of countries around the world. Explore. You will need to login before you can apply for a job. Senior Regulatory Affairs Specialist job in Brazil | ICON Regulatory Affairs Specialist WebJob details Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company! Collaborate with PI and on-site monitors in regards to new protocols, amendments, and continual review updates. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Entry Level Regulatory Affair Specialist jobs - Indeed Regulatory Affairs Specialist Ability to understand and explain detailed regulatory requirements, with particular proficiency in the US, Canada, and EU, and comply with constantly changing : $68K - $78K Unfortunately, this job posting is expired. Listing for: Bausch + Lomb. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. This button displays the currently selected search type. pre-submissions, IDEs, 510(k)s, Technical Files, etc.) WebThe major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below: Explaining regulations, policies, or procedures. By continuing to use this site, you are giving your consent to cookies being used. WebOur business encompasses many different functions and capabilities, which allows you to explore careers in various fields. Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. 9d Vertex We are dedicated to our employees continued growth and development, and we celebrate alongside you as you accomplish great things. The regulatory affairs specialist work description also involves advising project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues. Join us. Early talent programs can take many forms, including internships, academy programs, and leadership development programs. The .gov means its official.Federal government websites often end in .gov or .mil. Its time for a career you can be proud of. Prepare regulatory documentation, track regulatory activities, and ensure accuracy, Collaborate with PI and on-site monitors in regards to new protocols, amendments, and continual review updates, Ability to prepare, edit, and distribute templates, work instructions, SOPs, checklists, etc, Preparation of investigator/pharmaceutical company meeting minutes, Maintain Trial Master File and other electronic filing systems, Other administrative regulator support as assigned, 1 (one) year of experience with FDA Submissions (IND and IRB submissions a plus), Masters Degree in Public Health, Life Sciences, or related field or Ph.D preferred, Salary range: $75,000 - $95,000 (based on relevant experience), Benefits include: Health, Dental & Vision Insurance, 401k. Completes and maintains regulatory approvals and clearances of assigned products. Additional experience may be considered in lieu of a degree, Minimum of 3 years of relevant experience, Demonstrates critical thinking skills and the ability to apply this to daily workload decisions. Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. Job Description WebSpecialist, Regulatory Liaison, Regulatory Affairs International job in North Wales, Pennsylvania, United States of America | Regulatory Affairs jobs at Merck Residents of other markets, please click here. 13. Regulatory Affairs Specialist Regulatory affairs specialist Jobs in Boston Contact | Directions | Map WebSenior Regulatory Affairs Manager. Regulatory Affairs Specialist jobs in California - Indeed Regulatory Affairs Specialist Jobs, Employment Regulatory Affairs Specialist : $68K - $78K Unfortunately, this job posting is expired. This includes multilingual applicants for STEM positions. Full Time position. Create a job alert and receive personalized job recommendations straight to your inbox. What is the difference between a CRA and In-house CRA? All rights reserved. Full-time. Does a Regulatory Affairs Specialist Do 39 Regulatory Affairs Specialist Jobs in South Africa (4 new) It also presents the major requirements recruiters may want you to meet to be hired as a regulatory affairs specialist. Participate in system testing for upgrades by executing scripts and being involved in validation. Jobs at the Office of Regulatory Affairs (ORA) At ORA, you make a difference in protecting the health of the American people. Sign In. Regulatory Affairs Specialist Job Some employers also demand several years of proven work experience in a similar industry. It also includes determining the types of regulatory submissions or internal documentation that are needed in situations like labeling changes or proposed device changes. They create and monitor CMC change control for commercial and investigational product. Easy Apply RAC certification is a plus. You will author US regulatory submissions, European Technical Documentation, and support international product registrations globally. HHS Recruitment Information Webinar Part 4:Interviewing Techniques presentation by DeShan Mingo King, Senior Human Resource Specialist, U.S. Office of Personnel Management.
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