Regulatory Affairs Manager
The Manager of Regulatory Affairs is responsible for providing support and project leadership in the regulatory environment to achieve product approval in the US and the rest of the world. Responsible for supporting the regulatory strategy and preparing the associated submissions. This includes monitoring the FDA regulatory approval approach for compliance to regulations and guidance documents.
ESSENTIAL JOB FUNCTIONS
- Support, promote and ensure compliance to the Company regulatory strategy for product approval
- Author PMA supplements and other regulatory submissions for design and process
- Represent Regulatory Affairs in Operations meetings to assess product changes and possible regulatory impact
- Supports communication to FDA and International Regulatory Agencies.
- Take a project lead role as assigned in multiple projects that require analysis of data and compliance with established regulations and standards
- Take a lead role in maintaining and revising, as necessary, Regulatory Standard Operating Procedures
- Along with the VP Reg/Clinical and Quality provide regulatory expertise for the company’s pre-clinical and clinical studies, related directly or indirectly to marketing and associated promotions of Company products worldwide.
- Develop and maintain association with outside organizations and institutions pertinent to the interests and needs of the department and the Company.
Bachelor’s degree in engineering, science, business or related field
5 + years in regulatory management
5 + year within the medical device industry
Experience authoring PMA supplements for design and process
Experienced in assessing design and process changes to determine the regulatory reporting requirements (e.g., annual report vs. PMA Supplement)
Experienced in reviewing promotional materials and labeling to ensure compliance with applicable regulatory requirements
Experienced preparing and updating technical files in support of CE Mark
Experienced working on project teams to provide regulatory input and guidance
Successful record of reviewing product modifications for regulatory impact
Current or fairly recent experience in a start-up environment