Principal Regulatory Affairs Specialist - EMEA; Cluster Partner

Principal Regulatory Affairs Specialist - EMEA

The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction across our UK&I, Be Ne Lux  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 Cooper Vision products in a specified region.
• Communicates applicable regulatory requirements to Cooper Vision 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 Cooper Vision 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 Cooper Vision 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 Cooper Vision, 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 Cooper Vision 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.

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.
• 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…