12 days old

Regulatory Affairs Consultant

Monroeville, PA 15146
  • Job Code
  • Payrate
    $90 To $110

We are looking for a Sr. Regulatory Affairs Consultant for a role in Monroeville, PA

Education: Bachelor's /Master's degree or equivalent. Significant leadership experience in role.

Work independently on Regulatory duties, processes and roles outlined below:

1. Create and execute Regulatory Strategies and Plans for assigned medical devices in the US and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers. Participate and provide regulatory guidance to assigned medical device new product development and sustaining projects.

2. Primary responsibility for Regulatory submittals and assessments for the US, Canadian and EU markets.

3. Prepare and submit 510(k)'s and other product submissions according to FDA guidelines

4. Create and update European Technical File and Declaration of Conformity documents (MDD, R&TTE, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines

5. Review and approve product labeling plans, labeling, and marketing communications

6. Support the international regulatory team with inputs, as needed, into the registration packages they prepare and to address questions received from government agencies.

7. Support internal and external quality audits, as needed.


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Regulatory Affairs Consultant

Randstad Technologies
Monroeville, PA 15146

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Regulatory Affairs Consultant

Randstad Technologies
Monroeville, PA

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