Senior Regulatory Affairs Specialist
Johnson & Johnson Medical BV - Amersfoort (Nederland)
For our client, Johnson & Johnson Medical BV, we are looking for a Senior Regulatory Affairs Specialist.
As RA Specialist/Lead/Senior you will represent J&J in various internal forums, Trade Associations and also meetings with local Health Authorities/Competent Authorities.
You are the primary internal and external contact point within the region for all operational Regulatory Affairs needs.
Business Environment and Context:
- Management of specific regulatory requirements regarding Medical Devices and Drug distribution;
- Rapidly identify regulatory issues concerning MD, report them to Management and Franchise, investigate and suggest solutions to resolve them;
- Oversight and management of company license or registration for MDs, Human Tissue products and Drugs;
- Review and approval of promotional materials (Copy review for Medical Devices and Drugs);
- Review and approval 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, Customer Service (especially for tenders);
- Perform regulatory training 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 Affairs activities;
- Partner closely with internal partners across Johnson & Johnson to ensure that the stake holders' voices are evaluated within the strategies;
- Represent J&J in various internal and meetings with Local Health Authorities;
- Liaison with local Competent Authorities;
- Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures;
- Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials are compliant with Region guidelines and restrictions.
Who we're looking for
- B.Sc./M.Sc. in pharmacy, medicine, engineering, or science;
- At least 5 years of medical device and/or medicines regulatory affairs experience required in an International Company;
- Languages: English, Dutch, notion in French language will be appreciated.
- Profound knowledge of regulatory requirements for Medical Devices and Drugs;
- Ability to persuasively communicate and influence regulators and other key stake holders;
- Highly skilled in establishing partnerships and collaboration with business partners, Franchise RA and regional RA, as well as other stake holders;
- Strong results-orientation and sense of urgency;
- Solid capacity to analyse, interpret and synthesise on regulation and guidelines;
- Strong capability of self-awareness and adaptability.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
As pioneers in medical devices, we continually focus on elevating the standard of care – working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.
Additional vacancy information
|Contract||:||Direct contract with client|
|Employment terms||:||Salary: >4300|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 2 years
|Location||:||View location with Google Maps|
|Contactperson||:||Jan Paul Favier|
|+31 (0)88 22 77 555|
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