Regulatory Affairs Specialist

4 days ago

Cardiff, United Kingdom Eakin Healthcare Group Full time

**ABOUT THE ROLE**
Reporting to the Regulatory Affairs Manager the Regulatory Affairs Specialist based from the Cardiff site is responsible for supporting the group in ensuring requirements for medical device regulatory compliance are identified, achieved and maintained.

**KEY ACTIVITIES**
- 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.
- Effective inputs to maintenance of the QMS in relation to regulatory affairs, including, compiling and updating Technical Files, submitting technical Files for external audit and 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.
- Other duties include input into Risk Management, PMS, Design and Development, GSPR and Clinical Evaluation.
- Liaising with Business Development on new market entry projects.
- To undertake other duties as may be reasonably required.

**Other**
- 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

**KEY SKILLS**
**Essential**
- 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
- Proficient in MS office
- Ability to work as part of a team
- Methodical with analytical and problem solving skills

**Desirable**
- Full UK driving License
- Experience in Ostomy or Surgical products
- Knowledge of Medical Device regulations or Quality Management e.g. MDR, ISO 13485, UKCA

**KEY WORKING RELATIONSHIPS**
**Internal**
- Group operations
- QARA team
- R&D
- Commercial Teams

**External**
- Regulatory Bodies
- Notified Bodies
- Customers
- Suppliers

**ADDITIONAL INFORMATION**
- 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

**COMPETENCIES**
**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.
**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
**Information Gathering** - Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
**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 conclusion

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