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AI Summary
The Sr Manager, Regulatory Affairs provides strategic leadership for the Lifecycle Regulatory team, overseeing postmarket regulatory activities and compliance for commercialized products. They partner with business units and regulatory colleagues to execute global strategies, manage regulatory submissions, and ensure adherence to conditions of approval.
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)
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