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About the Role
A global biotechnology company is seeking an Associate Director, Device Regulatory Affairs to lead regulatory strategy for innovative medical devices supporting global development and commercialization. This role will drive regulatory planning across the product lifecycle, ensuring successful submissions and compliance in key international markets.
Responsibilities
- Lead the development and execution of global regulatory strategies for medical device products.
- Oversee regulatory submissions and documentation to support product approvals and lifecycle management across major markets.
- Provide strategic regulatory guidance to cross-functional teams throughout product development and commercialization.
- Monitor evolving global regulatory requirements and assess their impact on development programs and business strategy.
- Partner with global Regulatory Affairs, Quality, Clinical, and R&D teams to ensure regulatory considerations are integrated into development plans.
- Support interactions with regulatory authorities and coordinate responses to agency inquiries.
- Drive continuous improvement of regulatory processes and contribute to global regulatory best practices.
- Provide leadership and mentorship across cross-functional regulatory initiatives.
Requirements
- Strategic regulatory leader with strong technical expertise and sound business judgment.
- Experienced in influencing cross-functional stakeholders and driving alignment across global teams.
- Strong project management, communication, and leadership skills.
- Comfortable navigating complex regulatory environments and supporting innovative product development.
- Proactive, collaborative, and solutions-oriented.
- Experience with Class III medical devices or other highly regulated products.
- Knowledge of combination products or Software as a Medical Device (SaMD).
- Familiarity with global regulatory frameworks across the U.S., Europe, and other international markets.
- Regulatory Affairs Certification (RAC) or equivalent.
Skills
- Project management
- Communication
- Leadership
- Regulatory strategy
- Technical expertise
- Business judgment
- Influencing stakeholders
- Global team alignment
- Navigating complex regulatory environments
- Supporting innovative product development
- Collaboration
- Solutions-oriented
- Class III medical device experience
- Combination products knowledge
- SaMD knowledge
- Global regulatory frameworks (U.S., Europe, international)
Experience Level
- Associate Director
Benefits
- Lead regulatory strategy for innovative, cutting-edge medical technologies with global impact.
- Partner with international teams to shape regulatory pathways from development through commercialization.
- Take on a highly visible leadership role with broad cross-functional exposure and strategic influence.
- Contribute to bringing breakthrough technologies to patients worldwide.
About the Company
- A global biotechnology company