Sr. Manager, Regulatory Affairs

Department: Regulatory

Location: Gainesville, FL

Description

The Sr Manager, Regulatory Affairs provides strategic regulatory leadership across the full product lifecycle—from design concept and development through global market authorization, commercialization, post‑market lifecycle management, and product obsolescence.

This role partners with cross‑functional and global regulatory teams to develop and execute regulatory strategies that ensure compliance, enable product changes, and support sustained market access throughout the life of Advita products

Key Responsibilities

Design & Development

• 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

Regulatory Strategy & Market Authorization

• 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

Commercialization & Post‑Market Lifecycle Management

• 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

Compliance, Renewals & Conditions of Approval

• 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

Leadership, Governance & External Engagement

• 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

Education:

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

Experience:

• 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

Skills, Credentials, Knowledge:

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