Spécialiste principal en stratégie réglementaire assurant la conformité réglementaire des produits pharmaceutiques. Collaborant avec des équipes interfonctionnelles pour soutenir le développement de produits.
About the role
- Director of Global Regulatory Affairs leading regulatory strategy for AI medical devices in a dynamic healthcare company. Ensuring compliance and facilitating accelerated market access for innovative products.
Responsibilities
- Proven ability to own and drive end-to-end regulatory strategy from concept through commercialization, including portfolio prioritization and resource allocation aligned with business goals
- Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing agency interactions (e.g., interactive responses and presubmission meetings) to secure timely approvals
- Serve as the regulatory lead for the company, managing all interactions with regulatory authorities including pre-submissions, responses to deficiencies, inspections, and ongoing correspondence
- Partner with cross-functional teams (R&D, Clinical, Quality, Product, Commercial) to define and proactively embed regulatory requirements into product development workflows and align global market access strategies with business priorities
- Collaborate with Head of Quality to ensure the Quality Management System represents state-of-the-art practices and supports regulatory compliance and post-market surveillance programs
- Establish and lead a proactive regulatory intelligence program to monitor evolving global requirements (EU MDR, EU AI Act, FDA SaMD guidance, IMDRF standards), provide and implement strategic recommendations to executive leadership on product roadmap, risk mitigation, and competitive positioning
- Build and mentor a high-performing regulatory team while driving the continuous optimization of internal workflows and submission processes, establishing scalable processes that support rapid portfolio expansion while maintaining compliance excellence
- Ensure compliance with company policies and applicable laws across all regulatory activities, including adverse event reporting, clinical studies and evaluations, and labeling requirements
- Other duties as assigned
Requirements
- Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline); advanced degree preferred
- 10+ years of progressive regulatory affairs experience with Class II medical devices and Software as a Medical Device (SaMD), including hands-on submission authorship and successful FDA and international approvals (must provide specific K numbers)
- Deep expertise in global regulatory frameworks (FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP) and demonstrated ability to navigate complex, multi-jurisdictional pathways
- Proven track record managing regulatory authority interactions, including pre-submission meetings, deficiency responses, and regulatory inspections with favorable outcomes
- Strategic regulatory intelligence capabilities with ability to translate emerging requirements (AI/ML regulations, cybersecurity guidance) into actionable business recommendations
- Experience leading small but mighty regulatory teams in fast-paced, innovation-driven environments with rapidly evolving product portfolios
- Proficiency with regulatory information management systems, quality management software (e.g., Veeva Vault, MasterControl, Greenlight Guru), and submission platforms (eSTAR, EUDAMED)
- Strong communication, organizational, and problem-solving skills with ability to influence cross-functional stakeholders and present complex regulatory strategy to executive leadership
- Great track record of successful teaming and contributing meaningfully to company culture
- Ability to perform the essential functions of the role with or without reasonable accommodation.
Benefits
- The opportunity to work on products that impact the health of millions of people.
- Generous paid-time off
- Stock incentive plans
- Medical/Dental/Vision, Disability + Life Insurance
- One Medical membership
- Parental Leave
- 401k Matching
- Wellness programs and perks (Headspace, Ginger, Aaptiv, Physera)
- Learning and Development stipend
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior EHS Manager responsible for compliance audits and initiatives in Watts Industries' manufacturing locations. Monitoring regulatory changes and collaborating with teams to maintain EHS standards.
Director of Compliance and Risk at Voyager Asset responsible for managing risk and compliance policies. Ensuring investment integrity and adherence to regulations in a fast - paced environment.
Compliance Readiness Manager providing expert compliance support and ensuring adherence to regulations in Group Payments. Overseeing compliance readiness and driving initiatives for continuous improvement.
GRC Engineer at security team to strengthen governance, risk, and compliance programs. Collaborating with technical security engineers to protect customer data.
Vice President leading PCI governance, risk, and compliance for Synchrony. Collaborating cross - functionally to ensure PCI compliance and mitigate risks within the organization.
Director of Promotional Regulatory Affairs at AstraZeneca overseeing FDA compliance and regulatory strategy development. Collaborating with cross - functional teams to ensure promotional materials meet standards.
ITGC Compliance Manager at BAT overseeing compliance with IT General controls within the Digital Business Solutions. Supporting management to improve compliance measures and coordinate with stakeholders.
Regulatory Affairs Specialist ensuring compliance for Class III and IV medical devices in Brazil. Collaborating within a LATAM matrix structure to provide regulatory guidance and support.
QPPV Compliance Director supporting pharmacovigilance system quality and compliance at Pfizer. Collaborating with teams to meet regulatory requirements in international settings.