Overview As Regulatory Affairs Lead, you will shape global regulatory strategies for new and modified medical devices and guide cross-functional teams toward compliant submissions. You will manage independent problem solving, lead regulatory submissions, and train RA staff while partnering with authorities to align on feasible regulatory paths. Your work will influence product lifecycle decisions and labeling compliance across markets, driving risk-aware strategies. This role offers a strategic impact on development programs and a chance to influence regulatory outcomes at scale.
Responsibilities- Lead project submissions for regulatory approvals and resolve issues independently
- Apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking
- Develop sound global regulatory strategies for new and modified medical devices
- Prepare robust regulatory applications aligned with departmental and organizational objectives
- Create, review, and approve engineering changes
- Provide leadership and training to RA staff and cross-functional teams
- Review device labeling and marketing materials for compliance with FDA submissions and regulations
- Provide global strategic input to development teams with feasible alternatives and risk assessment
- Drive cross-functional alignment on issues with regulatory implications
- Interact with competent authorities (FDA and others) and build strategic partnerships
- Review product and manufacturing changes for regulatory compliance (Change Control)
- Review protocols and reports to support regulatory submissions
- Assess proposed regulations and communicate new requirements to the organization
- Support Company initiatives in relation to QMS, EMS, and other regulatory requirements
- Comply with FDA and international regulations, company policies, procedures, and tasks
- Maintain positive, cooperative communications across all levels of employees, customers, contractors, and vendors
Key requirements- 8+ years of technical experience
- 6+ years of medical device regulatory experience
- Extensive experience with US and global medical device regulations and submissions
- Ability to work in a highly matrixed and geographically diverse environment
- Strong leadership skills with ability to set goals and provide constructive feedback
- Ability to work effectively within a team in a fast-paced, changing environment
- Strong verbal and written communication across multiple organizational levels
- Multi-tasking, prioritization, and meeting deadlines
- leadership
- clear communication
- cross-functional collaboration
- regulatory submissions (FDA and international)
- Change Control
- QMS and EMS awareness
