The Principal Lifecycle Regulatory Specialist provides regulatory support of the Lifecycle (Postmarket) projects 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 Lifecycle Regulatory Specialist will partner with the cross functional team members (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.
Duties and Responsibilities (Key Deliverables):
1. Communicate directly with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies.
2. 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.
3. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.
4. Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the global regulatory strategy.
5. Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies environment.
6. Review and approve post-launch advertising and promotion (A&P)
7. Oversee compliance with any regulatory Conditions of Approval.
8. Support regulatory audits and inspections
9. Interpret and apply medical device regulations and standards
10. Know and apply the Quality System and any appropriate Federal and International standards.
11. Assist and support other employees, teams, and sales personnel as necessary.
Education: Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
Experience: • Minimum of 10 years’ experience in the medical device industry specifically in Regulatory Affairs.
• Bachelor’s Degree in physical or life sciences preferred.
• 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
Functional/Technical Knowledge, Skills and Abilities Required:
• Proficiency with windows-based office productivity tools (Microsoft Office)
Bachelors or better.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)