Job Description
Director of Regulatory Affairs - Medical Devices
Join to apply for the Director of Regulatory Affairs - Medical Devices role at Anteris Technologies
Director of Regulatory Affairs - Medical Devices
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Join to apply for the Director of Regulatory Affairs - Medical Devices role at Anteris Technologies
Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Reporting to the SVP of Clinical and Regulatory, the Director of Regulatory Affairs will support the strategic direction and lead the day-to-day execution of global regulatory activities. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance with global requirements related to market authorizations, post-market surveillance, and regulatory reporting.
At Anteris, you’ll be part of a high-caliber team advancing a transformative therapy for aortic stenosis. We value accountability, objectivity, respect, teamwork, integrity, and courage, and we’re united by a shared purpose: improving patient lives through disruptive innovation. We’re building something remarkable—and we’re just getting started.
Key Responsibilities
- Create and execute global regulatory strategy for all Anteris products in alignment with business goals.
- Serve as a strategic advisor to the executive team on the regulatory implications of product and process changes.
- Develop and lead a high-performing global Regulatory Affairs team that supports company objectives across product lifecycles.
- Oversee department budget planning and resource allocation to ensure alignment with regulatory and business priorities.
- Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.
- Lead timely renewals of global licenses, certificates, and product registrations.
- Provide guidance on the application of external standards across all projects.
- Maintain complete, audit-ready regulatory documentation and manage global submission packages.
- Direct regulatory activities related to field corrective actions and ensure appropriate product re-submissions and ongoing approvals.
- Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits.
- Monitor evolving global regulatory requirements and assess their impact on Anteris products and systems.
- Conduct regulatory assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products.
- Review Engineering Change Requests (ECRs) for global regulatory impact.
- Lead or participate in regulatory review of promotional materials.
- Author, review, and approve internal procedures related to regulatory affairs operations and compliance.
Skills, Knowledge, Experience & Qualifications - Bachelor’s degree in a technical field required; advanced degree preferred.
- 10–12 years of experience in the medical device industry, ideally with exposure to structural heart technologies.
- At least 5 years of experience leading a Regulatory Affairs team.
- Hands-on leadership of regulatory submissions for Class III/PMA devices, including FDA (IDE, PMA) and EU (MDR, CA, CE Mark) pathways.
- Experience working with Notified Bodies through CE submissions and post-market requirements.
- Strong knowledge of global regulatory standards and quality systems, including ISO 13485, GMP, GCP, GLP, QSR, and MDR.
- Exceptional communication skills with the ability to craft clear, concise regulatory documents and collaborate across functions and levels.
- Proven project management skills, with a track record of driving robust submissions and compliance initiatives.
- Innovative, solution-oriented mindset with a strong focus on regulatory rigor and business alignment.
- Demonstrated leadership that fosters cross-functional collaboration, champions innovation, and drives accountability.
- A disciplined, strategic approach to risk management and regulatory compliance.
- RAC certification preferred.
What We Offer:
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Collaborative and dynamic work environment with a culture of innovation and excellence.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings
- Medical, Dental, and Vision Plans
- Flexible Spending Account (FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
- Paid Holidays & PTO
- Employee Assistance Program
- Inclusive Team Environment
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale. Seniority level
Employment type
Employment type
Full-time
Job function
Job function
Legal Industries
Medical Equipment Manufacturing
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