Regulatory Affairs Advisor
Position Title: Regulatory Affairs Advisor
Position Summary: The Regulatory Affairs Advisor is a mid-level technical position.
The Regulatory Advisor will assist with the implementation of new global processes and procedures, facility registrations outside the US, and UDI implementation. He/she will determine the key regulatory procedures, ensure compliance to current medical device standards, adopt industry best practices where possible, and implement specific processes and procedures.
- Create, develop, and execute global regulatory procedures and quality processes.
- Track and manage the status of each document in the document control process.
- Clearly present obstacles and suggested solutions to the team lead.
- Review, revise, summarize and disseminate key updates and changes for product submissions.
- Create and execute regulatory compliance submissions and filings.
- Provide analysis of data and files to ensure compliance with company policies and external regulations.
- CE-Mark experience is desired. FDA, 510(k), and PMA experiences are required.
- Familiarity with UDI requirements for Class I, II, and III
- 3+ years experience in regulatory and/or quality compliance fields
- Minimum Bachelor’s degree in a scientific/technological field
- Strong problem-solving and communication skills
- Experience in regulatory-approval processes and requirements
- Excellent organizational skills
- Experience with document-management systems such as EtQ, Agile, etc.
- High work ethic with excellent time-management skills
- Experience in participating in cross-functional projects
- Ability to follow assigned tasks and meet aggressive project deadlines