Johnson & Johnson Loopbaan
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Regulatory Affairs Specialist
Requisition ID: 1805626241W
Based in the European HQ in Belgium, the Regulatory Affairs Specialist reports to the Manager, Regulatory Affairs -EU Strategy. This position assists and supports the CSS Regulatory Affairs – EU Strategy Department in the execution of regulatory activities.
DUTIES & RESPONSIBILITIES
Under general supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate
Johnson & Johnson, procedures and guidelines, this position:
- The RA Specialist is the primary point of contact with RA affiliates to contribute to the development and execution local registration strategy and renewals in compliance with relevant laws, regulations and organizational requirements of countries under his/her scope. This includes the planning and prioritization of new registrations, modifications to existing registrations and renewals activities in line with business objectives.
- The RA Specialist:
- Liaises with the manufacturer to obtain all necessary documents required for a submission and define submission strategy as necessary. Provides documentation on a timely manner, this includes but not limited to Certificates, Declaration of Conformity, labeling, Technical File, Design Dossier, preparation of draft letters;
- Facilitates discussions between EU based external manufacturers and CSS franchises to support projects in addition to obtaining regulatory documents to support global product registrations;
- Assists the Manager, Regulatory Affairs - EU Strategy in monitoring 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;
- Maintain regulatory requirements up to date for countries under his/her assignment.
- Prepares and implements regulatory strategies and processes to assure efficient processes and documentation of new requirements for CSS products in compliance with applicable Regional;
- Regulations and international standards;
- Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws regulations, standards, directives, guidance, Notified Bodies position papers;
- Assists the RA platform for any questions related to the new requirements and develop recommendations pertinent to the CSS portfolio;
- Participates in providing strategic guidance to CSS to assure efficient processes and documentation of new requirements for CSS products.
- Supports daily RA activities related to products under his/her portfolio:
- Serves as the EU regulatory SME for the portfolio under his/her responsibility and provides / monitors any specific regulations inherent to it;
- Partners closely with internal partners across Johnson & Johnson (including regional platform, Regulatory (legal manufacturer), Clinical, Medical Affairs, Quality, Product Stewardship, Marketing, Commercial) to ensure well defined regulatory strategies for product launches and product modifications;
- Partners with RALI and EU Registration Team representative to ensure timely registration of new product launches and product modifications;
- Approves ECO’s pertaining to the 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;
- Responsible for ensuring 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;
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;
- Performs other duties assigned as needed.
- A university degree or equivalent in Science, Engineering, Technical or Biomedical field or Law;
- 1-3 years – experience in Regulatory Affairs or Quality Affairs preferred.
- Fluent written and oral English communication skills;
- Good Computer skills: Outlook, Excel, Power Point;
- Good organization skills, effective time management, autonomous;
- Active listener;
- Conscientious, Detail oriented, Analytic;
- Team player.
- Interaction with External Manufacturers;
- Interaction with Ministries of Health.
- Interaction with Sponsors/Manufacturers Regulatory Affairs counterparts cross franchise, Clinical Operations;
- Departments, Johnson & Johnson local regulatory affiliates in EMEA, J&J owned pharmaceutical entities quality department, technical.
Johnson & Johnson Medical NV (7546)