ABOUT THE ROLE
Reporting to the Regulatory Affairs Manager for Eakin R&D, the Regulatory Affairs Specialist is responsible for supporting the group in ensuring requirements for medical device regulatory compliance are identified, achieved and maintained.
- Ensure adequate controls are in place for the manufacture of medical devices and that the product Technical Files are compliant with regulatory requirements.
- Ensure adequate control of documents and records is maintained.
- Ensure that confidential company information is protected.
- Maintaining medical device technical Files in line with regulatory requirements. Ensuring technical agreements are in place with critical sub-contractors and that they are being implemented effectively.
- Effective inputs to maintenance of the QMS in relation to regulatory affairs, including:
- Compiling and updating Technical Files.
- Submitting Technical Files for external audit.
- Communicating with Notified Bodies and resolving audit non-conformities within the designated deadlines.
- Undertaking vigilance activities and reporting adverse events
- Attend meetings as required and action outputs accordingly.
- Ensure that key information is relayed to relevant stakeholders as appropriate.
- Liaise effectively with other departmental management staff.
- Implementing extension to scope projects.
- New Technical File generation activities.
- Plan effectively for external audits of device technical files and report on the results to senior management.
- Product labelling and packaging development.
- Perform measurement, analysis and reporting of regulatory data.
- Communicating with other external agencies such as Competent Authorities.
- General Duties
- Input to customer complaint investigations
- Product design and development (inputs to)
- Design risk analyses
- Design validation
- Clinical risk mitigation
- Regulatory Affairs review
- Production of compliance reports
- Process development
- Liaising with Business Development departments on new market entry projects
Critical Success Factors
- Conduct regular risk management activities including performing product-related risk analysis to ensure compliance with requirements.
- Liaison during external and unannounced audits.
- Responding to internal requests for technical and/or regulatory information.
- Demonstrate continual improvement of the regulatory affairs function.
- Monitoring changes to regulatory legislation affecting the QMS.
- Support the Regulatory team in achieving and maintaining compliance with EU MDD, UK MDR, EU MDR, REACH, WEE, US FDA and other national regulatory authorities in countries where our products are used.
- Participate in external, internal and customer audits - taking responsibility for resolving non-conformance issues raised, relating to regulatory controls.
- Maintain and manage relationships with regulatory authorities.
- Develop and maintain awareness of regulatory changes on a national basis.
- Co-ordination and oversight of major regulatory clearance applications (e.g. US FDA 510(k) pre-market applications).
- Assisting relevant personnel with device registrations and licence applications as required.
- Preparing reports regarding adverse incidents and submitting reports to Competent Authorities.
- Assisting relevant personnel with product recalls, Field Safety Corrective actions and Field Safety Notices as required.
Product Development & R&D
- Ensure that regulatory requirements for product development work are completed in line with internal QMS requirements (for example Design Control and CE-marking) and that any such requirements, if applicable, are documented for inclusion in product Technical Files.
- Input to requirements for documentation for national product registration activities.
- Assist with Risk Management activities, including documentation of the risk management file, for new product development projects
- Assist with post market surveillance activities, including production and maintenance of PMS reports
- Managing projects with departmental Managers (Quality, Marketing, Production) and external contractors/suppliers, as required to meet the targets and goals of such projects, within agreed budgets.
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy.
- To adhere to the company’s Quality policy and Environmental policy.
- To undertake other duties as may be reasonably required.
- Degree educated in science, business, law or proven experience in a similar role
- Previous experience in a regulatory role
- Strong administration skills
- Meticulous with high levels of attention to detail
- Ability to work under pressure and to tight deadlines
- Effective team player with strong communication skills
- Proficient in MS Office
- Experience in the respiratory product area
- Previous experience in medical device manufacturing
- Knowledge of MDD, MDR, ISO13485
- Experience carrying out risk assessments
KEY WORKING RELATIONSHIPS
- Group Operations
- QARA Team
- Commercial teams
- Regulatory bodies
- Notified bodies
- Ability/willingness to develop within the role
- Ability/willingness to attend training courses in relation to the role and the needs of the department
- Ability/willingness to travel to other Eakin Healthcare Group sites if required
Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn’t dwell on past events.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Following Directions – Is motivated to accept and comply with standards and instructions and has a strong conscience about delivering what is promised or expected. Doesn’t like letting people down and works productively in cooperation with, and support of others.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
Technical expert –full breadth of technical knowledge and can operate as a technical advisor, influencing others to achieve goals without relying on hierarchy. Keeps up to date on changes within their field and implements plans to ensure organisation is in a state of readiness. Participates in industry and professional associations