Sr. Manager, Regulatory Affairs

Key Responsibilities

• Provide regulatory leadership and input during early product design and development to ensure global regulatory requirements are integrated into product strategy and development plans
• Interpret and apply applicable medical device regulations and standards to inform design, testing, and submission strategies

• Develop and execute global regulatory strategies and timelines to support product submissions, approvals, and registrations in the U.S., EU, and other international markets
• Communicate directly (and through team members) with regulatory agencies and health authorities regarding submissions, regulatory pathways, and strategic issues

• Oversee regulatory assessment and execution of design, manufacturing, labeling, and process changes to commercialized products, including regulatory impact assessments and submission deliverables
• Provide regulatory input to change teams on project and test plans to ensure alignment with approved regulatory strategies
• Oversee regulatory review and approval of post‑launch advertising and promotion (A&P), ensuring compliant and timely pre‑release review processes

• Ensure ongoing compliance with global regulatory requirements, including management of EU renewals and regulatory commitments
• Oversee compliance with Conditions of Approval and maintain systems and processes to ensure obligations are met on time
• Maintain awareness of the evolving global regulatory environment and assess impacts to lifecycle regulatory strategies

• Lead, develop, and oversee regulatory professionals responsible for full product lifecycle regulatory activities, including hiring, training, performance management, and workload prioritization
• Support regulatory audits and inspections
• Collaborate with trade associations and regulators to help shape the external regulatory environment.

Skills Knowledge and Expertise

• A minimum of a Bachelor’s Degree from an accredited institution, preferably in physical or life sciences; Master’s Degree preferred

• Minimum 8 years’ experience in medical device industry in regulatory affairs or related field, orthopaedic device industry
  experience preferred.
• Experience in US, EU and/or international submissions/registrations required
• Working knowledge of US, EU and international medical device regulations required
• Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required
• Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required
• Prior team leadership required
• Regulatory Affairs Certification (RAC) preferred

• Proficiency with windows-based office productivity tools (Microsoft Office)