Manager, Regulatory Affairs Strategy

Job title:

Manager, Regulatory Affairs Strategy

Company

Johnson & Johnson

Job description

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.
Key Responsibilities: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

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.

Experience and Skills:Required:

• Experience in Regulatory Affairs and EU Medical Device Regulation required
• Leverage deep knowledge of EU regulatory requirements and ability to translate regulations into clear data requirements to support CE-marking
• Ability to work effectively and navigate a complex organizational structure
• Strategic thinking and ability to partner and influence key stakeholders.
• Highly skilled in establishing partnerships with regional and Business Unit colleagues
• Strong communication, influencing and presentation skills

Preferred:

• Project Management experience is preferred.
• Previous experience with health authority meetings/interactions is strongly preferred.
• Experience in the cardiovascular/cardiology/aesthetic field is preferred.

Other:

• Self-motivated and committed to a team approach.
• Excellent written and verbal communications skills in English (required)
• This position may require 15%-20% domestic and/or international travel.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Expected salary

Location

Diegem, Vlaams Brabant

Job date

Thu, 16 May 2024 22:24:15 GMT

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