Authorised representative manager for IVD/MD

工作内容

WHAT IS OFFERED

• A dynamic working environment in a fast-growing company with an excellent international reputation.
• Support by an experienced team.
• The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics.
• The opportunity to use and develop your skills in a world class team of specialists.
• Fulltime contract
• Flexibility on remote work (a minimum of 2 days per week at the offices in Geel).
• The opportunity to manage an excellent service.

ABOUT THE COMPANY

The company is a fast-growing consulting company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. They help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and offer a unique solution for e- labeling, currently used by multi-billion-dollar medical device and IVD companies. From their offices in Geel, Eindhoven, Turin and other international locations they serve more than 250 customers worldwide.

JOB DESCRIPTION

The Authorised Representative Manager will lead a team of 4 people, covering the Authorised Representative Service (including UK service) of the company. He/she will report to the AR Director, who has strategic responsibilities but who will still act as a support for technical questions. The AR Service includes supporting IVD/MD manufacturers in bringing their products to the EU market by reviewing technical documents on a high level and finally notifying the authorities.

Besides leading the team, reviewing technical documentation and communicating with clients, the AR manager will coordinate on a more process level: assign the projects to the team members, keeping guard of the timelines, keeping track of invoicing of clients, …

We are welcoming candidates who have a scientific background in IVD/MD with RA and people management experience, and who have excellent organizational skills.

Responsibilities:

• Leadership of Authorised Representative service
• Establish, implement and maintain the Quality System processes under category “Authorised Representative” in agreement with regulatory requirements
• Correct and efficient execution of Authorised Representative tasks and responsibilities, including relevant communication to the competent authorities.
• Contribute to achieve financial and other objectives (KPI). Communicate KPI to team members.
• Integrate information security controls within the processes for Authorised Representative service
• Ensure that the technical documentation of clients is up to date
• Protecting the client’s regulatory interests

Authorities:

• Advise Authorised Representative Director and Personal Responsible for Regulatory Compliance in decision taking on Incident and FSCA reporting
• Execute Incident and FSCA reporting
• Make technical documentation available upon demand of competent authority
• Define and communicate information security responsibilities and duties for employees, contractors and other third parties regarding Authorised Representative service
• Perform notifications of IVDs and MDs

REQUIRED COMPETENCES & SKILLS

Education:

• Master or engineering degree in sciences or technology

Experience:

• Minimum 7 years relevant experience in regulatory affairs function or minimum 7 years of experience in IVD, MD or biotech industry
• 1-3 years of leadership experience

Languages: English

Computer: Microsoft applications: Word, Excel, Outlook

Other: Organized, customer focus, teamwork, writing skills, mentoring, effective communication, proactive, autonomous, flexible attitude, enjoy working in an international environment, people management skills