Personalized precision heart health
Vice President, Regulatory Strategy and Innovation
Location
United States + 1 moreAll locations: United States, Portugal
Posted
19 days ago
Salary
Not specified
No structured requirement data.
Job Description
Job Requirements
- B.S. or higher degree in a Life Science, Engineering, or related discipline.
- JD preferred.
- Regulatory Affairs Certification (RAC) highly preferred.
- Minimum 15+ years of progressive Regulatory Affairs experience.
- Experience with Class II/III cardiovascular devices strongly preferred.
- Minimum 7–10 years of leadership experience.
- Demonstrated experience defining global regulatory strategy under EU MDR.
- Proven record of executive engagement with global regulatory authorities.
- Deep understanding of software development lifecycle (SDLC) and agile methodologies.
- Experience integrating regulatory strategy into product development and commercialization planning.
- Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure strongly preferred.
- Ability to synthesize complex regulatory landscapes and define clear long-term direction.
- Integrating regulatory insights into portfolio prioritization and commercial strategy.
- Ability to align and influence cross-functional and executive stakeholders.
Benefits
- Base Salary: $280,000 - $300,000
- Total Target Compensation (TTC): $336,000 - $360,000
- 20% target annual bonus
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