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Sr. Regulatory Affairs Specialist

Seattle, Washington 98108 | Direct Hire

Post Date: 01/05/2018 Job ID: 17905 Industry: Other Area(s)

Position Title:  Sr. Regulatory Affairs Specialist

Position Description:  Protingent Staffing has an exciting opportunity with our client in Seattle, WA. 

Job Requirements:

  • Responsible for supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance and recall coordination.

  • Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.

  • Manage response for regulatory requests from customers, distributors or regulatory agencies.

  • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.

  • Maintain company registrations and device listings in the US, Canada, and the EU.

  • Support/maintenance of technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.

  • Recall coordinator for product recalls.  

  • Support and report departmental metrics and reports to executive management.

  • Provides support and backup for other QA/RA functions.

  • Supports internal/external audits and regulatory inspections.

  • Perform other quality assurance and quality control functions as necessary, with appropriate training.

Job Qualifications:

  • Bachelor' s Degree (B.S.) from a four-year college or university in Engineering, Bio-Medical Engineering, Sciences or related field.

  • Minimum 6 years of Regulatory Affairs work  experience in medical device (Class II and Class III).

  • Strong knowledge and experience with 510(k) preparations and submissions required.

    • Must have demonstrated experience with submissions in Canada and EU.

    • Experience with international countries a plus.

  • Current knowledge of FDA and International quality system regulations required.

  • Specific experience following Device Design Controls and Risk Management Processes.

  • Experience with Electronic Medical Equipment preferred.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Gazelle Medina

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