Regulatory Affairs Specialist II

  • Location
    Santa Clara, California
  • Job type
    Contract/Temporary
  • Category
    Office, Clerical & Administrative - Administrative Assistant

Adecco is currently assisting a local client in their search to fill an exciting role of an Affairs Specialist II in Canoga Park, CA,! Apply now if you meet the qualifications listed below!






SUMMARY OF PURPOSE/FUNCTION:





Position Summary:
The Regulatory Affairs Specialist II 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
Key Responsibilities:

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
Minimum Requirements/Qualifications

Bachelor’s degree in Biology, Chemistry, bio-engineering or related scientific area or two years’ experience in the device / diagnostic, biologic, and / or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products
2 years of IVD Regulatory Affairs experience
Well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
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

Preferred Qualifications:

Post-market experience in ISO 13485

This position has not been approved for Relocation Assistance.
















Position Summary:






How to Apply: Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities, available at Adecco go to www.adeccousa.com.

If you have any questions surrounding the application process, please feel free to reach out to Leonor REYES at Leonor.Reyes@adeccona.com

The Adecco Group is a global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities.

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Reference number US_EN_2_022862_404962