senior regulatory affairs specialist johnson & johnson

• Under RA responsibility and in accordance with all applicable federal, state and local

  laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  
  Is a critical partner for the CSS International Execution team in the EMEA region:

  • Coordinates, compiles, and submits Free Sales Certificates.
  • Gathers and assembles information necessary from the manufacturer for submissions to support product registration internationally.
  • Supports the international team upon request to develop relationships with RA affiliates, contributing to the development and execution of local registration strategy. This may include planning, prioritization and preparation of responses to regulatory agencies’ questions and other correspondence for new registrations, product modifications and renewals.
  • Serves as an EU regulatory SME for the portfolio under his/ her responsibility, supporting daily RA activities.
  • Assists in developing strategic guidance and recommendations to CSS regulatory requirements pertinent to the Franchise.
  • Reviews EMEA internal and external communications that reference products and/or disease state information (Copy Review Process) and represents CSS in relevant forum.
  • Advises and provides regulatory impacts to Supply Chain initiatives for CSS, is the Primary Point of Contact for the regulatory distribution controls of medical devices & support associated processes and system development.
  • Writes, reviews and revises company SOPs, recommends efficiencies to processes and drives Engineering Change Orders (including but not limited to SOPs, EU labeling approval).
  • Supports announced and unannounced inspections by external and internal functions.
  • Assists with organizational tasks: departmental meetings (logistics, formatting, minutes) and department PO’s, handling regulatory fees (Ariba).
  • Partners closely with internal partners across Johnson & Johnson (including Legal Manufacturers, Importers, Distributors, Regional Regulatory Affairs, Quality, Supply Chain Marketing and Medical Affairs) to ensure that the stakeholders’ voices are evaluated within strategies for product launches and product modifications.
  • Develops solutions to a variety of problems of moderate scope and complexity in which data analysis requires an evaluation of intangible variables.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

• • Master or bachelor (Science, Engineering, Technical or Biomedical field or Law preferred).
  • 4-6 years – experience in Regulatory Affairs or Quality Affairs preferred
  • Good knowledge of medical device regulatory requirements in the EU
  • Work effectively in a matrixed organization and in establishing partnerships with regional and Franchise colleagues
  • Project Management Skills
  • Proactively identify new insights and solutions
  • Strong communication, influencing and presentation skills
  • A strong results-orientation and sense of urgency
  • Excellent written and verbal communications skills in English (required)

You can fill this position through Randstad Professionals as a consultant (with an employee or freelancer contract)

In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as

• Gross salary according to your experience
• Lunch vouchers of €7 per day worked
• Net remuneration of €80 per month
• Company car with fuel card (subject to conditions) or Mileage allowance
• Hospitalisation insurance
• 1 extra day’s holiday per month worked
• End of year bonus
• Pension Plan
• ECO vouchers worth €250 (on an annual basis, pro rata)
• Training opportunities