Manager, Regulatory Affairs Strategy

at  Johnson Johnson

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Tech sector within Johnson & Johnson, is recruiting for a Manager, Regulatory Affairs Strategy.
The preferred location for this role is within a commutable distance of Diegem, Belgium however remote work options from EMEA may be considered on a case-by-case basis and if approved by the Company.
The Manager, Regulatory Affairs Strategy develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable European regulations and international standards. Exhibiting a strong knowledge of EU regulations regarding product design, development, manufacture and distribution, the Manager, Regulatory Affairs Strategy monitors and assess the impact of product specific regulations.

EDUCATION:

• Bachelor’s degree with 5-8 years of experience or PhD, Pharm, Masters, legal degree with adequate experience required.
• Advanced degrees and education in medicine, engineering, science or law preferred.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provides strategic guidance and develops pertinent recommendations to CSS related to regulations and relevant guidelines
• Provides advice, counsel and expertise on RA issues, both proactively and reactively, to project teams
• Demonstrates deep domain expertise in the regulatory requirements for EU & CE registrations
• Develops and leads the regulatory aspects for supply chain initiatives for CSS
• Oversees and supports the process for the control of the distribution of medical devices in accordance their regulatory requirements and registration status.
• Collaborates and partners with cross-functions across Johnson & Johnson (including Legal Manufacturers, Importers, Distributors, Marketing, R&D, Regional Regulatory Affairs, Quality, Clinical and Medical Affairs) to ensure that the collaborators’ voices are evaluated within strategies for product launches and product modifications
• Provides clear and timely communication of new and changing requirements and educates Business Unit Associates on those requirements for integrating into procedures
• Represents CSS in various internal and external forums - including policy (acting as expert on company/product impacts and product advocacy)
• Supports announced and unannounced inspections by Competent Authorities and internal functions
• Ensures adherence to standard operating procedures and protocols, and adjusts processes, reduce complexity to improve efficiency or align with compliance requirements
• Identifies and facilitates continuous improvement activities