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Regulatory Affairs Specialist

2 maanden geleden

Breda, Noord-Brabant, Nederland ZEISS Group Voltijd
Key Responsibilities

The Regulatory & Quality Specialist Benelux will be responsible for ensuring the Quality Management System (QMS) and Regulatory compliance in the Benelux region. This includes liaising with the Management System Officer (MSO) and other managers and staff to ensure the QMS is functioning properly.

Key Accountabilities
  • Promote quality achievement and performance improvement throughout the organization.
  • Set local QA compliance objectives based on corporate guidance and ensure regular review of the defined objectives.
  • Establish and implement the necessary communication strategy for the improvement and awareness of quality and regulatory issues across all departments.
  • Organize yearly internal audit program in cooperation with Local MSO and HQ Quality team and coordinate external (re)certification audit with Corporate external certification partner.
  • Manage reimbursement of products and technologies in local markets.
  • Liaise with the ZEISS external agencies on changes in the local regulations & communicate accordingly within the local ZEISS organization.
  • Cover Medical Device Regulations (MDR)/Quality related questions coming from the market & liaise with HQ on these topics.
  • Act as the point of contact for Regulatory incidents and take necessary actions.
  • Provide information and training to employees on regulatory requirements and changes in regulations.
  • Maintain documentation related to regulatory compliance such as product registrations.
  • Negotiate and follow-up on GDPR contracts.
  • Support on Tender questions related to Regulatory & Quality.
Requirements

The ideal candidate will have a legal or scientific degree (BSc, MSc) or similar and at least 4 years of working experience in the field of medical devices (EU-MDD and EU-MDR) through positions in industry, consultancy or Notified Body, in either quality, regulatory or clinical roles.

The candidate should be familiar with risk management of medical devices, pragmatic and enjoying a mix of activities in regulatory affairs or quality assurance. Strong communication and service-oriented skills are essential, as well as the ability to deal with various projects at the same time, detail-oriented and precise.

Fluent English and Dutch language skills are required, French is a plus. The candidate should be willing to travel between our Zaventem and Breda offices and live in the Antwerp area.

About ZEISS Group

ZEISS Group is a dynamic and interdisciplinary organization that stimulates creative thinking and innovation. We offer development perspectives and flexibility in the organization, and we care about our employees and take our responsibility for improving society and preserving our environment.

We work in the Benelux at 3 locations: Breda in the Netherlands, Zaventem and Heverlee in Belgium. In total, about 185 employees work in the Benelux. We have our own Experience Center in Breda, where we let our employees and customers experience the ZEISS feeling.

What We Offer
  • An attractive salary that suits the position.
  • An annual bonus.
  • Holiday allowance 8,33%.
  • 25 holidays.
  • Training and development opportunities.
  • A cool annual kick-off with the entire Benelux organization.