25 days old
2017-11-212017-12-19

Regulatory Specialist

Andover, MA 01810
  • Job Code
    588931
  • Payrate
    $38 To $43

We are looking for a Regulatory Affairs Operations Specialist


Responsible for:


- Managing the FDA establishment registrations and device listings process for all Philips facilities. Providing input to management regarding Philips-wide establishment registration strategy.


- Managing the medical device manufacturer/distributor US state licensing process for Philips facilities.


- Owning the FDA Certificates to Foreign Government and embassy authentication submission strategy and execution for all Philips businesses.


- Owning and maintaining the regulatory deliverables database across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals.


- Owning and maintaining department procedures related to the above responsibilities


- Notarizing regulatory documents.


Education & Training:


- Bachelor's degree in a related technical or business discipline.


- A minimum of 3 years related experience in the medical device industry.


- Working knowledge of FDA medical device regulations. Experience with FDA establishment registration, medical device manufacturer/distributor US state licensing, and/or Certificate to Foreign Government applications desirable.


Competencies:


- Familiarity with managing Microsoft SharePoint sites.


- Demonstrated ability to effectively interact with employees and managers on all levels.


- Goal-oriented and proactive in problem solving.


- Strong written and verbal communication skills.


- Attention to detail.


- Must be able to perform responsibilities with minimal supervision.

Categories

  • Information Technology

Randstad utilizes a technology-driven focus with a human touch to provide better staffing and business solutions to organizations around the world. Our team of experts match professionals with available career opportunities in a variety of fields.

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Regulatory Specialist

Randstad Technologies
Andover, MA 01810

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Randstad Technologies
Andover, MA
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