Compliance Analyst supporting internal controls and conducting investigations for Brazil's largest Out of Home media company. Collaborating on compliance policies and training.
About the role
- Senior Regulatory Affairs professional leading global medical device regulatory strategy at Lexington Medical. Focused on enabling product development and regulatory compliance for surgical devices.
Responsibilities
- Lead and author regulatory submissions for U.S. and international markets, including 510(k)s, EU MDR technical documentation, and design dossiers
- Own regulatory strategy and execution for new product development programs from early concept through commercialization
- Serve as the regulatory representative on cross-functional product development teams, ensuring regulatory requirements are integrated throughout the product lifecycle
- Support ongoing regulatory compliance activities, including change order review, design change assessments, and maintenance of existing clearances and approvals
- Review and approve product labeling, instructions for use, and related materials to ensure regulatory compliance
- Maintain awareness of evolving global regulations, standards, and guidance, including FDA requirements, EU MDR, MDSAP, ISO 13485, and ISO 14971
- Participate directly in regulatory correspondence and interactions with regulatory authorities such as the FDA and Notified Bodies
- Partner closely with Quality, Manufacturing, and Commercial teams to support audits, inspections, and day-to-day regulatory operations
Requirements
- Bachelor’s degree in Engineering, Science, Regulatory Affairs, or a related technical field
- Typically 5–15+ years of experience in medical device regulatory affairs
- Demonstrated ownership of FDA submissions as well as EU technical documentation
- Extensive experience with post-market surveillance, including complaint handling support, vigilance reporting, trending, and regulatory maintenance activities
- Experience with complex medical devices, including electromechanical systems and software-enabled products
- Working knowledge of international regulatory frameworks and standards, including EU MDR, MDSAP, ISO 13485, and ISO 14971
- Strong written and verbal communication skills and the ability to influence cross-functional teams
- High attention to detail combined with sound judgment and the ability to manage multiple priorities in a fast-paced environment
- Ability to operate independently while partnering closely with engineering, quality, manufacturing, and commercial teams
- RAC certification is a plus, but not required.
Benefits
- Travel occasionally to Bedford, MA to spend time in-person with colleagues
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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