Sr Manager, Regulatory Affairs

Advita Ortho; Northern (KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Advita Ortho in the US (Remote) seeks a Sr Manager, Regulatory Affairs to provide strategic leadership for the postmarket regulatory team, directing regulatory strategies, submissions and ongoing compliance for commercialized orthopaedic products. You will collaborate with BU/regional teams, health authorities, and cross-functional partners to ensure timely approvals and lifecycle management.

The role requires 10+ years in medical device regulatory affairs, US/EU experience, RAC preferred, and a

Qualifications

• Minimum 10 years' experience in medical device regulatory affairs.
• Experience with US/EU/international submissions required.

Responsibilities

• Lead the Lifecycle (postmarket) regulatory team and oversee regulatory strategies and timelines.
• Coordinate with health authorities and cross-functional partners to ensure compliance and approvals.
• Ensure postmarket regulatory support for changes, including A&P reviews as applicable.

Skills

Regulatory strategy

Communication with health authorities

Regulatory leadership

Education

Bachelor’s Degree in life sciences

Master’s Degree preferred

Tools

Microsoft Office

Job description

Sr Manager, Regulatory Affairs

Department: Regulatory

Employment Type: Full Time

Location: US (Remote)

Reporting To: Sr. Global Regulatory Affairs Director

Description

The Sr Manager, Regulatory Affairs provides strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team accountable for Advita’s postmarket regulatory affairs, i.e., regulatory support of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Sr Manager, Regulatory Affairs will partner with the business (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.

Key Responsibilities

• Oversee the regulatory professionals who manage Advita’s Lifecycle (postmarket) RA: recruit, hire, train, develop and direct the work activity of LC RA personnel
• Communicate directly (also through LC RA team members) with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies
• In partnership with the business and regulatory colleagues (e.g., BU, Operations, and the BU, Regional and RO & RCoE RA teams) develop and execute regulatory strategies and timelines to support proposed changes to commercialized product. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.
• Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the project regulatory strategy
• Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies
• Collaborate with trade associations and regulators to help shape the regulatory environment
• Oversee the regulatory review and approval of post-launch advertising and promotion (A&P); implement and maintain processes to ensure robust and timely pre-release review of A&P
• Oversee compliance with any regulatory Conditions of Approval; implement and maintain systems and/or processes to ensure conditions are met on time
• Support regulatory audits and inspections Interpret and apply medical device regulations and standards

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 10 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

Functional/Technical Knowledge, Skills and Abilities Required:

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