Principal Regulatory Affairs Specialist

Job title: Principle Regulatory Affairs Specialist DACH

Department: Regulatory Affairs

Location: Darmstadt Germany

Working hours: Full time

A brighter future awaits you

CooperVision is one of the worlds leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improvethe way people see each day. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were all about bright futures for our people and those who wear our contact lenses.

Job summary What to expect:

The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction across our D-A-CH cluster ( including some Eastern Europe locations) for products from concept to launch and beyond into post market as well as regulatory processes. This roleis responsible for delivering highquality regulatory partnership and ensuring market access across a the cluster. Operating as a strategic regulatory partner to Cluster Leadership Teams thePrincipal Regulatory Affairs Specialist drives regulatory strategies that enable business growth and safeguard CooperVisions license to operate. This role is accountable for developing and executing regulatory strategies driving highquality regional submissions ensuring compliance with EU MDR and regional regulations and maintaining accurate auditready regulatory documentation.

Responsibilities include:

1. Regulatory Strategy & Leadership

• Develop and execute regulatory strategies for assigned clustermarkets aligned to commercial priorities and lifecycle needs.
• Serve as the primary regulatory partner to Cluster Leadership Teams providing expert actionable guidance.
• Lead creation and improvement of regional regulatory processes SOPs and best practices.
• Represent RA in crossfunctional meetings providing clear regulatory direction and riskbased decisionmaking.

2. Cluster Partnership & Commercial Collaboration

• Participate in Cluster Leadership Team activities influencing commercial planning forecasting and launch decisions.
• Provideregulatory impact assessments for clusterbusiness strategies promotions NPLCOs and private label initiatives.
• Partner with Global Packaging/Labelling to ensure compliant labelling aligned to market needs.

3. Registration & Market Access

• Prepare review and approve regulatory submissions for assigned EMEA markets covering new registrations renewals amendments and notifications.
• Maintain accurate complete and auditready submission documentation and databases
• Support interactions with Competent Authorities Notified Bodies and regulatory agencies.

4. Monitoring & Intelligence

• Monitor regional and national regulatory changes and assess business impact.
• Communicate relevant regulatory intelligence to cluster and regional leadership promptly.
• Establish and maintain productive relationships with government industry groups and regulatory bodies.

5. Labelling Advertising & Product Compliance

• Review and approve product labelling and clusterspecific artwork.
• Provide RAinput into Regulatory Affairs Impact Documents (RAIDs).
• Ensure adherence to MDR marketspecific requirements and CooperVision policies.
• Support Own Brand/Private Label customers and associated regulatory obligations.

6. Technical Documentation & Audit Activities

• Review and assess technical documentation for compliance with MDR and other applicable regulations.
• Contribute to technical audits and inspection readiness within assigned markets.
• Support responses to Notified Body queries audit findings and corrective actions.

7. CrossFunctional & Regional Contribution

• Mentor and guide junior specialists working on clusterrelated submissions or activities.
• Contribute to continuous improvement initiatives across EMEA RA.

A full job description is available upon request.

About you:

Skills & Abilities

• Understanding of ISO 13485 MDR and regional EMEA regulations.
• Ability to analyse technical information and develop robust regulatory strategies.
• Excellent organisation prioritisation and communication skills.
• Ability to partner effectively across commercial and technical functions.
• Skilled in regulatory submissions technical documentation and labelling review.
• Comfortable operating inmulticultural and matrixedenvironments.
• Skilled at influencing stakeholders and leading without authority.

Experience & Education:

Required:

• 610 years regulatory experience within the medical device industry.
• Demonstrated experience preparing and submitting regulatory filings in EMEA.
• Experience supporting audits and technical documentation reviews.
• Track record of highquality stakeholder partnership ideally with commercial teams.

• Experience in electronic document management systems.

Preferred:

• Advanced degreeand/or Regulatory Affairs Certification desirable.

What we offer:

Youll receive competitive compensation and a fantastic benefits package and accessto our Wellness Platform to support you in mental health and wellbeing a discounted contact lens scheme and much more!

We are committed to our employees personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals well give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.

What you can expect:

As a CooperVision employee youll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

If you like what you see take the first step towards your Brighter Future and apply today!All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page at view all other opportunities.

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