The Senior Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines. This position will be located in Canoga Park, CA.
Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues.
Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews.
Develops the regulatory strategy for project team(s).
Applies advanced regulatory expertise to the evaluation and solution of submission problems.
Actively reviews and edits documents associated with product development meetings.
Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR’s.
Review and interpret scientific literature and summarize effectively in writing.
Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
Ensure training and compliance with global quality system regulations.
Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
Bachelor’s degree in Biology, Chemistry, bio-engineering or related scientific area.
5 years of IVD Regulatory Affairs experience to include either 510(k) or PMA Submissions.
Well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirement.
Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
Experience in the balance and application of regulatory requirements.
Direct and positive experience in communicating with Regulatory Authorities and Distributors.
Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
Strong oral and written communication skills, as well as the ability to provide scientific presentations.
Ability to compile data and summarize results.
Hands-on, action-oriented, and able to implement effectively through his/her team.
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
Able to work autonomously in a matrix-managed organization.
Post-market experience in ISO 13485
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Internal Number: 86065BR
About Thermo Fisher Scientific
As the world leader in serving science, we empower our people to advance innovative technologies, develop meaningful solutions, and build rewarding careers. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our 70,000 extraordinary minds the resources and opportunities to make significant contributions to the world.