Watertown, United States
over 1 year ago
• Ensuring product approvals are obtained and maintained based on planned markets.
• Developing plans and procedures to achieve compliance to EU Medical Device Regulation.
• Communicating with regulatory sources on behalf of the company in relation to quality or regulatory matters.
• Maintaining knowledge of advances for the industry with regard to US and International standards and norms.
• Providing regulatory information and risk-based assessments for the design, service and other technical functions in the company. Review quality related documentation for compliance with the company’s requirements and regulatory requirements.
• Supporting Management Team to accomplish product cost (COG) reduction and incremental profitability of the company without sacrificing quality and integrity of the product.
• Overseeing, maintaining, and creating Quality System documentation and regulatory files.
• Reviewing and approving validation activities.
Qualifications / Experience Requirements
• Minimum of 7-10 years regulatory affairs experience with emphasis in the medical device industry.
• Working knowledge of current FDA Quality Systems Regulation and other countries may become necessary.
• Hands on experience with product documentation and the preparation of 510(k)s, and international dossiers/technical files.
• Bachelor's Degree in Engineering