Regulatory Affairs Lead, Benelux

Role Description: RA Specialist/Lead/Senior

Represent J&J in various internal forums, Trade Associations, and also meetings with

local Health Authorities/Competent Authorities.

Be the primary internal and external contact point within the region for all

operational Regulatory Affairs needs.

Ensure Regulatory Compliance of Medical Devices (MD) for their access to the local markets (Benelux) for the full product life cycle – Compliance with both local requirements (Netherland, Belgium, and Luxembourg) and EU-MDD (from May 2021 EU-MDR).

Job Title: Regulatory Affairs Specialist MD, Benelux

Location: working remote currently, the contract could be in NL or BE

min. 1-2 days per week onsite after restrictions (Amersfoort, Geleen) 

Working hours: 40/week

Contract until: 31/12/2021

Ideal start date: June/July 2021

3-5 years of relevant experience

- Must be EU Citizen

EN & Dutch-speaking, FR strong plus

Medical device experience

Experience in Reg. Affairs is a must

3 year+ experience

·       

Pre-regulatory authorization;

·       Management of specific regulatory requirements regarding Medical Devices and Drug distribution;

·       Identifying rapidly 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, Veterinary products, and Human Tissue products;

·       Review and approval of promotional materials (Copy review for Medical Devices and Drugs);

·       Review and approval of labeling of MDs and Drugs in the local language;

·       Provide regulatory support (in collaboration with franchises and EMEA/US Regulatory Affairs) to marketing, sales representatives, Customer Service (especially for tenders);

·       Performing 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 stakeholders' 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.

Required:

·       Required education: Bachelor's degree.

·       Advanced degrees and education in pharmacy, medicine, engineering, or science.

·       A minimum of 3-5 years of medical device and/or medicines regulatory affairs experience required in an International Company.

·       Languages: English, Dutch, notion in the French language will be appreciated.

Experience, skills and competencies, leadership competencies:

·       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.

Preferred: N/A