25 days old

Regulatory Specialist

Andover, MA 01810
  • Job Code
  • 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.


- 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.


  • 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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