Senior Regulatory Affairs Specialist

4 weeks ago

England, United Kingdom Mosaic Regulatory Solutions Full time

Role - Principal Regulatory Affairs Specialist
Location - Hampshire or Remote ( must be based in UK or Europe )
Role Status- Perm
Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Responsible for supporting the development and administration of global regulatory policy positions across product lines by preparing EMEA regulatory submissions for the full range of product approvals. This responsibility includes working independently with Marketing, Product Development, Consultants and Dealers to consolidate information and documentation required for regulatory filings in numerous countries within EMEA. Providing support for plans to achieve identified corporate regulatory policy objectives. Also develops related strategies and tactics to achieve stated business unit objectives subject to regulatory authority oversight which affects business. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or business directly. To share some of the responsibilities of the Person Responsible for Regulatory Compliance, with shared specific responsibility for the sub clause(s) of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745 described below.
The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction to 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.
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
Communicates applicable regulatory requirements to Regulatory Affairs management and business partners.
Analyses impact and communicates 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 positions
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.
Represents the perspective of regulatory affairs to the company.
Interprets general business objectives and effectively present information to manager and regions.
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 aUK EU, ACE & MENA perspective.
Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively 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 practices, public policy, business interests; Support RA compliance activities as necessary in assigned regions
Independently manage multiple projects, department initiatives and day to day tasksPRRC
This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. Travel Requirements:
Position may require occasional (5%) local or international travel to facilities, government
agencies, Customers, trade shows or training courses.
Understanding of ISO 13485 requirements and EU medical device regulations. 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. Flexible and able to self-manage multiple priorities.
Full, current driving license
Office/Hybrid/Remote environment. Prolonged use of a computer.
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 experience 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.
Extensive network-building and contact experience.
Capability to interact effectively and credibly at senior levels.
Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations.
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