Somerville, NJ
Contract Duration: 6-36 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:
- Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.
- Potenitial Remote
- Collaborate with cross-functional project team members and commercial partners to oversee the regulatory aspects of Complexity Management project changes and ensure the project timelines are met and in compliance with world-wide regulations and Directives.
- Prepare US, EU, and International Regulatory impact assessments for design, packaging, manufacturing, and labeling changes.
- Prepare submissions to U.S., EU, and International health authorities, as required.
- Ensure all regulatory documents are complete, accurate, and well-maintained.
- Prepare regulatory labeling requirements specifications for new and modified products and review product labeling to ensure compliance.
- Respond to product information requests.
- Research and collect information and data to support periodic reports to regulatory agencies
- Represent Regulatory Affairs on cross-functional project teams. Prepare and submit IFU/label changes to BSI (based on project strategy and timelines).
- Prepare 510(k)'s to FDA pertaining to indications for use changes, where needed (based on project strategy and timelines).
- Prepare and submit product and packaging design changes, along with manufacturing site changes to BSI.
- Submit notifications to country affiliates pertaining to product design, packaging, manufacturing site changes and provide necessary documentation to country affiliates (based on project strategy and timelines).
- Daily communication and meeting attendance with Complexity Management project teams, where needed.
- Daily or weekly communication with company Regulatory Management on Complexity Management project status and deliverables
- Bachelor's Degree
- 5+ years Regulatory Affairs with Medical Device submission FDA and EU
- 510k submission experience and related above noted experience
- Can work with minimal supervision and capable of doing project work.