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Regulatory Affairs Manager


Waltham, MA
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Job Details

Volt Workforce solutions is working with one of the largest privately owned vitro diagnostic companies in the world.
The Manager of Regulatory Affairs reports to the Senior Director, Regulatory Affairs. Responsibilities include managing and supporting a variety of regulatory projects, including:

+ Determining effective regulatory pathways for a variety of products types

+ Participate in cross-functional teams to implement the regulatory strategies for the timely support of project team goals

+ Ensure that product development projects and changes to existing products are conducted in compliance with the appropriate regulations

+ Prepare Pre- IDE, 510(k), CE Mark Technical File and other related regulatory filings- US and International. Provide leadership and ensure the timely and accurate filing of regulatory documentation.

+ Interface with FDA, Notified Bodies, and other international regulatory agencies regarding regulatory submission strategy and approval reviews.

+ Collaborate with R&D and MASA to determine and execute pre-clinical test plans in support of regulatory submissions,

+ Maintain current knowledge of competitive technologies in addition to medical and technical developments related to the company's products.

This position requires an advanced degree in Sciences; 10+ years' experience in RA in medical or in vitro diagnostic devices including experience with and knowledge of FDA and International regulations and directives. Results oriented and flexible with multiple projects and priorities. Effective team member. Excellent written and oral skills. Excellent organizational and multi-project management skills and attention to detail. Regulatory Affairs Certification (RAC) preferred
Strong leadership, inter-personal, organizational and communication skills required.

**Volt is an Equal Opportunity Employer**

**Full Benefits and Relocation Assistance!**

**Debra Brock**

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