Principal Regulatory Affairs Specialist

CooperCompanies•Darmstadt, IN

2d•Remote

About The Position

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 role is responsible for delivering high-quality regulatory partnership and ensuring market access across the cluster. Operating as a strategic regulatory partner to Cluster Leadership Teams, the Principal Regulatory Affairs Specialist drives regulatory strategies that enable business growth and safeguard CooperVision’s license to operate. This role is accountable for developing and executing regulatory strategies, driving high-quality regional submissions, ensuring compliance with EU MDR and regional regulations, and maintaining accurate, audit-ready regulatory documentation.

Requirements

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 in multicultural and matrixed environments.
Skilled at influencing stakeholders and leading without authority.
6–10 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 high-quality stakeholder partnership, ideally with commercial teams.
Experience in electronic document management systems.

Nice To Haves

Advanced degree and/or Regulatory Affairs Certification desirable.

Responsibilities

Develop and execute regulatory strategies for assigned cluster markets 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 cross-functional meetings, providing clear regulatory direction and risk-based decision-making.
Participate in Cluster Leadership Team activities, influencing commercial planning, forecasting, and launch decisions.
Provide regulatory impact assessments for cluster business strategies, promotions, NPLCOs and private label initiatives.
Partner with Global Packaging/Labelling to ensure compliant labelling aligned to market needs.
Prepare, review and approve regulatory submissions for assigned EMEA markets, covering new registrations, renewals, amendments, and notifications.
Maintain accurate, complete, and audit-ready submission documentation and databases.
Support interactions with Competent Authorities, Notified Bodies and regulatory agencies.
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.
Review and approve product labelling and cluster-specific artwork.
Provide RA input into Regulatory Affairs Impact Documents (RAIDs).
Ensure adherence to MDR, market-specific requirements, and CooperVision policies.
Support Own Brand/Private Label customers and associated regulatory obligations.
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.
Mentor and guide junior specialists working on cluster-related submissions or activities.
Contribute to continuous improvement initiatives across EMEA RA.