Job title: Principal Regulatory Affairs Specialist - EMEA
Department: Regulatory Affairs
Location: Southampton, UK / Gorinchem, Netherlands or Gothenburg, Sweden
GLS: P04
Working hours: UK – 37.5 hours per week, Netherlands or Sweden – 40 hours per week
A brighter future awaits you
What to expect:
The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction across our UK&I, BeNeLux and Nordic Clusters, for products from concept to launch, and beyond into post market, as well as regulatory processes. The Principal RA Specialist articulates and executes the agreed regulatory strategy for assigned corporate projects. Leads the creation, development, and implementation of global/regional regulatory affairs procedures for marketed products and to maintain, update or remediate company’s regulatory compliance status.
Essential Functions & Accountabilities:
Registration Activity
Reviews and approves regulatory documents for the registration of current and new products in assigned markets.
Oversees the maintenance of submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Maintains, updates and remediates regulatory files and documents as required. This includes maintaining communication across the EMEA RA team and other departments, sites, or business units, to provide regulatory status reports.
Coaches/Mentors more junior team members with submission
Monitoring Registration Requirements within Region
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 communicate to management changes in regulations or requirements that have been identified.
Establish and leverage working relationships with government, regulatory agencies, and trade associations for the purpose of advocating CooperVision positions
Technical Documentation
Reviews compiled Technical Files for CE approval prior to submission
Supports RA Management with Notified Body requests for information.
As required, plays a significant role in technical audits in the UK, EU, ACE and MENA region, i.e. preparation, contingency planning, response, findings and close out activities.
Support to CooperVision Processes
Represents the perspective of regulatory affairs to the company.
Interprets general business objectives and effectively present 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 reflect positively on CooperVision, The individual conveys a trustworthy, credible, and reliable image at all times.
Act as a resource to the regions on quality issues and propose changes to minimise risks and enhance quality, reliability, safety and productivity.
Act as spokesperson, when appropriate, regarding CooperVision practices, public policy, business interests; arrange for technical explanations from internal or external experts.
Support RA compliance activities as necessary in assigned regions
Independently manage multiple projects, department initiatives and day to day tasks
About you:
Experience:
- 6-8 years of medical device regulatory experience.
- Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions.
- Medical device industry experiences including strong working knowledge and experience with MDD and MDR.
- Ability to operate in a business-driven model providing quick, salient analysis and concrete action plans emphasis on 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.
- Extensive network-building and contact experience.
- Capability to interact effectively and credibly at senior levels.
- Experience in electronic document management systems
Strong IT skills, problem solving ability, analytical and communication skills.
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Knowledge, Skills and Abilities:
- Understanding of ISO 13485 requirements and EU medical device regulations.
- Ability to read and understand technical material.
- Excellent attention to detail
- Excellent organizational skills
- Excellent written and verbal communication skills.
- Excellent organizational skills.
- Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. 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
Full, current driving license
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What we offer:
You’ll receive competitive compensation and a fantastic benefits package.
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, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision.
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.
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