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Senior Regulatory Affairs Specialist

Job Description

Based in the European HQ in Belgium, the Senior Regulatory Affairs Specialist develops and implements regulatory strategies and processes to assure timely global commercialization of CSS products in compliance with applicable European regulations and international standards.

RESPONSIBILITIES

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

•Supports regulatory activities for economic operator and supply chain initiatives for CSS, including those for European Authorized Representative
•Is a critical partner for the CSS International Execution team in the EMEA region
•Develops and sustains relationships with RA affiliates as their primary point of contact, contributing to the development and execution of local registration strategy. This includes planning, prioritization and preparation of responses to regulatory agencies' questions and other correspondence for new registrations, product modifications and renewals.
•Liaises with the manufacturer to obtain all necessary documents and prepares international documentation to support product registration internationally
•Facilitates discussions between EU based external manufacturers and CSS franchises to support projects in addition to obtaining regulatory documents to support global product registrations
•Monitors developments in EU/EMEA legislation and guidelines related to the medical device industry. Researches and interprets regulatory requirements and guidance to define Regulatory strategy impact assessment and execution plans. Maintains regulatory requirements up to date for countries under his/her assignment
•Assists the RA platform with any questions related to the new requirements and develops recommendations pertinent to the CSS portfolio
•Provides solutions to a variety of problems of moderate scope and complexity
•Writes, reviews and revises company SOPs as required
•Partners closely with internal partners across Johnson & Johnson (including Legal Manufacturers, Importers, Distributors, Marketing, R&D, Regional Leaders, Clinical and Medical Affairs) to ensure well defined regulatory strategies for product launches and product modifications
•Approves ECOs pertaining to the Senior Specialist’s projects and duties (including but not limited to SOPs, EU labeling approval)
•Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with applicable regulations (Copy Review Process)
•Primary Point of Contact for the distribution of medical devices in accordance their regulatory requirements and registration status (Item Restriction)
•Primary Point of Contact for customization activities in the European Distribution Center (Late Stage Customization process) assuring compliance to global market requirements
•Responsible for communicating business related issues or opportunities to next management level
•For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
•Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
•Performs other duties assigned as needed

Qualifications

EXPERIENCE AND EDUCATION

•A university degree or equivalent in Science, Engineering, Technical or Biomedical field or Law
•A minimum of 4 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
•Or advanced degree + 2 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

•Knowledge of medical device regulatory requirements in the EU
•Fluent written and oral English communication skills
•Good Computer skills: Outlook, Excel, Power Point
•Ability to work effectively in a highly matrixed organization
•Project Management Skills
•Problem Solving Skills
•Presentation Skills

Senior Regulatory Affairs Specialist

Johnson & Johnson Services, Inc, Machelen
Engineer, Developer
Master
Senior