CooperVision
Senior Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
Department: Regulatory Affairs
Location: Southampton, UK or Gothenburg, Sweden
Grading Level (GLS): P03
Working Hours:
- UK: 37.5 hours per week (Monday to Friday)
- Europe: 40 hours per week (Monday to Friday)
About the Role
A brighter future awaits you
The Senior Regulatory Affairs Specialist will provide regulatory support and direction to products from concept to launch. They will follow and implement the regulatory strategy for assigned corporate projects, ensuring global regulatory affairs procedures comply with company standards and regulatory compliance obligations.
The role partially fulfils the responsibilities of the Person Responsible for Regulatory Compliance (PRRC), as outlined in Article 15(3) of the MDR, in a shared capacity.
Key Responsibilities
Registration Activity
- Prepares, compiles, and submits regulatory documentation for:
- Current and new product registrations in assigned markets.
- Maintenance of submission databases for accuracy, completeness, and timely access.
- Monitors pending regulatory submissions to ensure timely approvals, escalating delays to management as needed.
- Tracks expiry dates of approved registrations, ensuring refresh submissions are initiated proactively.
- Collaborates with stakeholders including:
- Regulatory agencies, consultants, contract manufacturers, and distributors.
- Independent research or contractors to clarify registration requirements.
- Maintains regional/national regulatory knowledge and communicates updates to CooperVision teams.
- Analyses regulatory changes and advises management on business impact.
Monitoring & Technical Documentation
- Authoring regulatory files:
- STED and GSPR documents.
- Notified Body submissions in accordance with CooperVision technical procedures for MDD/MDR.
- Supports RA management for Notified Body requests for information (RFIs).
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Support to Corporate Processes
- Represents regulatory affairs perspective across the organisation, translating business objectives into actionable regulatory insights.
- Collaborates with global teams to review and approve product labelling, aligning with UK, EU, ACE & MENA regulatory criteria.
- Engages with:
- Customers (Own Brand/Private Label) and EU Competent Authorities/Ministries of Health.
- Regulatory Affairs Impact Documents (RAIDS) with multi-regional insights.
- Undertakes compliance tasks, ensuring smooth CE marking and regional registrations.
- Maintains professionalism in interactions, upholding CooperVision’s image with credibility, reliability and trust.
- Supports quality & risk activities, proposing adaptations to mitigate challenges and enhance safety/productivity.
- Communicates CooperVision practices to stakeholders (internal/external) and coordinates technical explanations from experts when needed.
- Assists RA compliance activities in assigned regions.
Required Qualifications & Experience
Education & Background
- Bachelor’s degree in a scientific or technical discipline (preferred).
- 3–6 years of experience in medical device regulatory affairs (essential).
- Strong technical writing skills.
Core Experience
- Experience in:
- Manufacturing change assessment for regulatory submissions.
- EU medical device regulations (MDD and MDR).
- Extensive network-building capabilities.
- Proficiency in electronic document management systems.
Key Knowledge & Skills
- Detailed understanding of:
- MDR 2017/745 EU, alongside UE harmonised standards (ISO 13485).
- Technical proficiency to read and interpret documentation.
- Organisational skills with:
- Excellent attention to detail.
- Highly developed verbal/written communication.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Intermediate knowledge of relational databases (e.g., Agile Project Management).
- Ability to work independently or collaboratively.
- Time management to meet deadlines with minimal supervision.
- Experience with product labelling inspections & approval.
- Multitasking flexibility to manage diverse priorities.
- Capacity to operate in multinational/multicultural teams.
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Industry & Strategic Skills
- Proactive problem-solving: reports to senior leadership with strategic collaboration.
- Relationship-building: influence internal/external stakeholders.
- Market awareness of industry/policy developments.
- Industry-recognised business acumen.
Benefits & Career Development
CooperVision offers a competitive compensation package, including:
- Health cash plan
- 25 days of holiday
- Pension scheme
- Life assurance
- Wellness & mental health support programs
- Discounted contact lens scheme
Development & Culture
- Prioritises career growth through tailored training programs.
- Access to LinkedIn Learning for ongoing upskilling.
- Inclusive workplace culture with proactive networks:
- African Descent Team
- Women’s Impact Network
- Mind-Body Wellbeing Recource Group (recognised as CooperPride partners).
Take the next step towards your future—apply today! All qualified candidates will receive equal consideration.
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