Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 5/24/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Regulatory Affairs Specialist
Location: Westford, MA
Employment Type: Full Time, Contract
Pay Range: 50-60/hr.
Duration: 4 months+
Regulatory Affairs Specialist
We are seeking a Regulatory Affairs Specialist 2 responsible for domestic and international regulatory activities associated with FDA, ISO, and international regulations. This is a Level 2 position.
Duties & Responsibilities:
- Support RA team in obtaining and maintaining approval to market IVD medical devices in worldwide markets.
- This may include the following: Participate, as directed, in new product development teams to coordinate preparation of regulatory content for domestic and international submissions for IVD medical devices (CE, US, Australia, Canada, and other international markets).
- Involvement in the preparation of Pre-Sub, FDA 510(k), PMA and PMA Supplement submissions
- Complete reviews of design control documentation to ensure compliance with domestic and international regulatory requirements for IVD medical devices.
- Develop and execute submission strategies for assigned projects.
- Monitor progress on key project deliverables and provide status updates on regular basis.
- Monitor and assess regulatory impacts of new and revised regulations, guidance, and standards.
- Support teams’ daily operations such as change reporting assessments, complaint assessment for Vigilance/MDR, Recall, Field Safety Corrective Actions (FSCAs).
- Develop and/or revise regulatory policies and procedures to keep current with constantly evolving regulatory and compliance environment.
- Prepare post-market reports for marketed devices as required in the US and abroad.
Looking for 4-5 years of experience
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776