Senior Regulatory Affairs Specialist in Southampton

Job Description

Job title: Senior Regulatory Affairs Specialist
Department: Regulatory Affairs
Location: Southampton, UK or Gothenburg, Sweden
GLS: P03
Working hours: 37.5 hours (UK) or 40 hours (Europe) per week Monday to Friday

Job Summary

The Senior Regulatory Affairs Specialist will provide regulatory support and direction to products from concept to launch. The Sr. RA Specialist follows the regulatory strategy for assigned corporate projects. Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and ensuring the company’s regulatory compliance status. The Senior Regulatory Affairs Specialist fulfills some responsibilities of the Person Responsible for Regulatory Compliance, per Article 15 (3) of the MDR, in a shared capacity.

Essential Functions & Accountabilities

Registration Activity

• Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets.
• Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
• Monitors pending submissions to ensure timely approvals and communicates to management any identified delays that may impact business expectations.
• Monitors approved registrations in respect to expiry and ensures management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
• Interacts with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.
• Works with in‑country representatives, contractors or performs independent research to determine regulatory requirements for product registrations in responsible regions.
• Maintains up‑to‑date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing CooperVision products in a specified region.
• Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.
• Analyses impact and communicates to management changes in regulations or requirements that have been identified.

Monitoring Registration Requirements within Region

Details of monitoring responsibilities are included within Registration Activity responsibilities.

Compilation of Technical Documentation

• Authors STED and GSPR documents and compiles Notified Body submissions in line with CooperVision Technical documentation procedures for MDD and/or MDR.
• Supports RA Management with Notified Body requests for information.

Support to CooperVision Processes

• Represents the perspective of regulatory affairs to the company.
• Interprets general business objectives and effectively presents information to manager and regions.
• Reviews and approves product labelling; initiates IFUs and other required product labelling in line with relevant UK, EU, ACE & MENA requirements.
• Supports “Own Brand” and “Private label” customers and liaises with EU Competent Authorities and other Ministries of health as necessary.
• Provides input to Regulatory Affairs Impact Documents (RAIDS) from UK EU, ACE & MENA perspective.
• Undertakes other administrative tasks to support CE marking and regional registrations.
• Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on CooperVision, conveying a trustworthy, credible, and reliable image at all times.
• Acts as a resource to the regions on quality issues and proposes changes to minimise risks and enhance quality, reliability, safety and productivity.
• Acts as spokesperson, when appropriate, regarding CooperVision practices, public policy, business interests; arranges for technical explanations from internal or external experts.
• Supports RA compliance activities as necessary in assigned regions.

Qualifications, Experience, Knowledge, Skills and Abilities

• Bachelor’s degree in a scientific or technical discipline preferred.
• 3-6 years of medical device regulatory experience.
• Technical writing experience.
• Experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
• Medical device industry experience including strong working knowledge and experience with MDD and MDR.
• Extensive network‑building experience.
• Experience in electronic document management systems.
• Working knowledge of medical device regulations strongly preferred.
• Understanding of ISO 13485 requirements and EU medical device regulations.
• Ability to read and understand technical material.
• Excellent attention to detail.
• Excellent organization skills.
• Excellent written and verbal communication skills.
• Intermediate skill in the use of Microsoft Office Suite, specifically Word, Excel and Outlook, and some knowledge of relational database systems such as Agile Project Management system.
• Ability to work effectively either alone or as part of a team.
• Managing time effectively and completing tasks on time with general supervision.
• Experienced at reviewing and approving product labelling.
• Flexible and able to self‑manage multiple priorities.
• Able to work effectively in multinational/multicultural environments.
• Flexibility to work across the UK sites.
• Ability to operate in a business‑driven model providing quick, salient analysis and concrete action plans emphasising understanding and anticipating business needs and interests and devising proactive approaches/responses.
• Must have the ability to build relationships and influence decision makers.
• Comprehension of industry developments and changes in the political environment.
• Capability to interact effectively and credibly at senior levels.

What we offer

You’ll receive competitive compensation and a fantastic benefits package including a health cash plan, 25 days holiday, pension scheme, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and more.

EEO Statement

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.