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Senior Regulatory Affairs Specialist

POSITION:  Sr. Regulatory Specialist

Company Name: Thermo Fisher Scientific
Location: Canoga Park, CA
Job Type: Regular Full Time
Contact Name: Sonali Juneja
Phone: 503-726-7502
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: D.O.E.

Job Description:

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 West Hills, CA.

  • 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.
  • 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.
  • Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR’s.
  • 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

Job Requirements:

  • 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. 

 
Apply today! http://jobs.thermofisher.com REQ #86065BR
 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.