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Role - Principal Regulatory Affairs Specialist
Location - Hampshire or Remote ( must be based in UK or Europe )
Salary - Negotiable
Role Status- Perm
Scope:
Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing, R&D, Operations and Marketing to provide any necessary information and documents (outside the Master Technical Files), requested by the regions to assist in global product registration activities. 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.
Job Summary:
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.
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 products in a specified 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
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 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 aUK 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 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; 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 tasksPRRC
Ensures that, per Article 15 (3) of the MDR:
the technical documentation and the EU declaration of conformity are drawn up and kept up-to- date;
the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR;
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued.
This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.
Travel Requirements:
Position may require occasional (5%) local or international travel to facilities, government
agencies, Customers, trade shows or training courses.
Qualifications
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 organization 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
Work Environment:
Office/Hybrid/Remote environment. Prolonged use of a computer.
Light lifting and bending.
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 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.
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.
Education:
Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations.
