Regulatory Affairs Specialist, Benelux

Regulatory Affairs Lead Medical Devices, Benelux

Overall purpose of job:

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).

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.

Collaborate with Manufacturers, Authorized Representatives, and Global Teams, regarding Dutch and Belgian legislation and related requirements.

Job Title:

Regulatory Affairs Lead Medical Devices, 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:May 2023 (two-year contract)

Ideal start date: June/July 2021

5+ years of relevant experience

EN, NL a must, FR plus

Medical device experience

Leadership experience plus

Essential duties and responsibilities:

•          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;

•          Update of RA database.

•          Handle all necessary activities for the release of SKU (codes) restrictions.

•          Local Management of the MV Project and related communication to all stakeholders.

•          Ensure regulatory compliance of Medical Devices (MD) for their access to the market of Belgium, Netherlands and Luxembourg.

•          Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, report them to the relevant RA Leaders (at the global and local level), investigate and suggest solutions to resolve them.

•          Support for One MD Organizations in Netherlands and Belgium related to the Project.

•          Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs, and act as the main contact person for any natters related to the Project impact issues.

•          Collaborate with local Commercial, Marketing, Tendering, Finance & Supply Chain teams, to ensure flawless completion of the Project and related activities, and accurate and timely reply to stakeholder requests.

•          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.

Special requirements:

Language requirement: Excellent in English and Dutch (write, read and speak)

Advanced level in Excel (mandatory & non-negotiable)

An analytical, self-motivated, energetic, and self-disciplined person

Problem solver

Fast learner

Good communication skills

Attention to detail

Able to work in a high-paced environment

Other features of the job:

Knowledge of EU Medical Device requirements will be beneficial

Previous experience in Medical Devices or Pharma industry will be beneficial

Required:

•      Required education: Bachelor's / Master'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 regulation and guidelines;

•      Strong capability of self-awareness and adaptability.

Preferred: N/A

Preferred: N/A