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Sr. Director of Regulatory Affairs
Custom Search, Minneapolis, Minnesota, United States, 55400
Our science-driven medical device client is redefining expectations and advancing the field through cutting-edge solutions and therefore hiring a Sr. Director of Regulatory Affairs. The Sr. RA Director reports to the SVP of Clinical and Regulatory Affairs and will support the strategic direction, as well as 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. Are you a Regulatory Director looking to fast-track to VP, then this role is for you!
Your role with the company:
Create and execute global regulatory strategy for all 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. Desired Profile:
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.
Your role with the company:
Create and execute global regulatory strategy for all 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. Desired Profile:
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.