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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.
  • You are the point of contact for Regulatory incidents and act upon them.
  • 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 (e.g. Regulatory Affairs Specialist or & Quality and Regulatory manager).

The candidate should be familiar with risk management of medical devices, pragmatic and enjoying a mix of activities in regulatory affairs or quality assurance. They should be strong communicative and service – oriented and have developed strong organizational skills. They should be able to deal with various projects at the same time, detail oriented and precise. They should speak and write fluent English and Dutch, French is a plus.

The candidate should like to travel between our Zaventem and Breda offices and live in the Antwerp area.

What We Offer

Within ZEISS we stimulate creative thinking and innovation. We work in dynamic and interdisciplinary teams and offer you development perspectives and flexibility in the organization. We care about our employees and take our responsibility for improving society and preserving our environment. These core values ​​have defined our corporate culture at ZEISS for more than 175 years.

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. Our locations stand for flexibility and vitality. It is also important for us to work completely digitally, and we offer an inspiring workplace that matches our brand identity. The ZEISS brand is therefore visibly recognizable in all workspaces.

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, and a pleasant work environment with open and inspiring culture and colleagues.