J&J Family of Companies Senior Specialist Regulatory Affairs Benelux in Amersfoort, Netherlands

Johnson & Johnson Medical is part of Johnson & Johnson and is responsible for commercialization of the Medical Devices Portfolio. For more than 100 years, we’ve focused on advancing technologies, products and services to enhance patient care and bring greater precision to every aspect of surgery. The office is located in Amersfoort, The Netherlands.

Through the training, research and innovative products we provide, we are working to enable better outcomes in bariatric, thoracic, colorectal and general surgeries. http://www.ethicon.com/ https://www.biosensewebster.com/

The Global Orthopaedics business of DePuy Synthes is comprised of Joint Reconstruction, Trauma, Spine, Sports Medicine, Neuro and Power Tools. Collectively, these businesses are focused on helping patients along the care continuum — from early intervention to surgical replacement, with the goal of helping people return to living active and fulfilling lives. https://www.depuysynthes.com/

At Johnson & Johnson every colleague makes a vital difference. Our people take pride in improving people’s health around the world. Each day, they make life better by going for high quality and continuous innovation. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Johnson & Johnson.

This position is to serve as Benelux ( Belgium, Netherlands and Luxembourg) Regulatory Affairs Specialist to ensure regulatory compliance of Medical Devices ( MD) and Drugs for their access to local market and follow-up their life cycle.

  • Pre-regulatory authorization

  • Management of specific regulatory requirements regarding Medical Devices and Drugs distribution

  • Identifying rapidly regulatory issues concerning MD, report them to Management and Franchise, investigate and suggest solutions to resolve them

  • Support compliance with local applicable environmental regulations ( WEE/Batteries/Packaging/RoHS …)

  • Oversight company license or registration for MDs, Veterinary products and Human Tissue products .

  • Review and validation of promotional materials ( copy review for Medical Devices and Drugs)

  • Review and validation of labelling of MDs and Drugs in local language

  • Provide regulatory support ( in collaboration with franchises and EMEA/US Regulatory Affairs) to marketing, sales representatives, customers, Customer Service ( especially for tenders): communication of regulatory documents or information answers to regulatory questions on products.

  • Performing regulatory training and assessments for marketing, MD sales representative and all other J&J MD relevant employees

  • Review and update of processes and procedures linked to all relevant Regulatory Activities

  • Partner closely with internal partners across Johnson & Johnson to ensure that the stakeholders' voices are evaluated within the strategies

  • Represent J&J in various internal and external forums as trade associations, meetings with Local Health Authorities.

  • Liaison with local Competent Authorities

  • Work collaboratively with the regional policy to ensure consistency of policy shaping activities and all activities linked to regulatory Intelligence

  • Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.

Qualifications

  • Bachelor's degree required. Advanced degrees and education in pharmacy , medicine, engineering, or science. A minimum of 5-8 years of medical device and drugs regulatory affairs experience required in an International Company

  • Fluent in English and Dutch, notion in French language will be appreciated.

  • Profound knowledge of regulatory requirements for Medical Devices and Drugs

  • Ability to persuasive communicate and influence regulators and other key stakeholders

  • Highly skilled in establishing partnerships and collaboration with business partners, Franchise RA and regional RA, as well as other stakeholders

  • Strong results-orientation and sense of urgency

  • Solid capacity to analyze, interpret and synthesize on regulation and guidelines

  • Strong capability of self-awareness and adaptability

Primary Location

Netherlands-Utrecht-Amersfoort

Other Locations

Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Brussels

Organization

Johnson & Johnson Medical BV (7260)

Job Function

Regulatory Affairs

Requisition ID

1700201088W