Overview As Regulatory Affairs Leader for the Aortic Business Group, you will steer global regulatory strategies and submission planning to secure and maintain approvals for Class III implantable devices. You will lead the Regulatory team and provide guidance to Regulatory Associates, aligning regulatory activity with cross-functional product development and business goals. You'll partner with leadership to ensure timely, compliant submissions and effective regulatory execution across geographies. This remote role offers the opportunity to shape regulatory strategy in a fast-paced medical device environment and drive impact on critical patient care.
Responsibilities- Provide direction for regulatory team members on pre- and post-market strategies, submission planning, and agency discussions
- Lead and manage Regulatory Associates, setting goals and coordinating projects
- Drive continuous improvement of regulatory processes to ensure compliant submissions and timely approvals
- Collaborate with cross-functional teams (Clinical, Product Specialists, Technical) to align expectations
- Partner with Regulatory Affairs Business Leader to meet business and regulatory objectives
- Share knowledge to develop regulatory deliverables expertise, including labeling and promotional compliance
- Communicate changes in global regulatory requirements within the function and with other teams
- Handle additional responsibilities within the scope of the role
Key requirements- Bachelor's degree and 8+ years in medical device Regulatory Affairs
- Extensive knowledge of FDA and international regulations for Class III implantable devices with PMA experience
- Proven track record in managing complex global regulatory strategies
- Experience influencing cross-functional teams to meet timelines
- Willingness to coach Regulatory Associates on assessments, strategy, and submission writing
- Experience with regulatory strategies or submission planning amid shifting timelines
- Experience assessing changes to device design, materials, manufacturing methods, packaging, or sterilization
- Direct people leadership experience
- Ability to prioritize work and adapt to changing priorities
- Strong communication and organizational skills; travel up to 15%
- leadership
- cross-functional collaboration
- adaptability
- FDA and international regulations for Class III implantable devices
- PMA submissions
- regulatory strategies and submission planning
