A growing medical device distributer requires an experienced Regulatory Affairs Specialist to join its team. You will be responsible for the day to day management and co-ordination of the technical documentation review process for technical files and creation of such files as per requirements of the ISO13485 standard and Medical Devices Regulations. To be considered, you must have proven experience supporting a medical device regulatory environment, including the writing of technical files.
You will be responsible for supporting the Quality Management Systems within the business ensuring compliance to ISO 13485, Medical Devices Regulations and other ISO standards. To work closely with the Quality & Regulatory Affairs Manager to develop and deliver a range of proactive and responsive QMS initiatives. You will also be responsible for the day to day management and co-ordination of the technical documentation review process for technical files and creation of such files as per requirements of the ISO13485 standard and Medical Devices Regulations.
- To undertake the day to day management and co-ordination of the technical documentation review process for technical files and creation of such files as per requirements of the ISO13485 standard and Medical Devices Regulations.
- To support the medical devices supply chain product release & to deputise for Quality and Regulatory Affairs Manager to ensure continuity of service delivery.
- To assist with training related to the Quality Management Systems to all levels of staff within the business.
- To assist with investigating and managing customer complaints and to respond to technical enquiries.
- To assist with the management of change control with sub-contractors and support new product development by assisting in providing expertise to ensure QMS requirements are achieved.
- To participate in continuous improvement, corrective actions and business risk minimisation.
- To assist in initiating and maintaining supplier assessment reviews.
- Plan and conduct internal audits for QMS standards and follow up as directed and assist in hosting audits by external regulatory bodies/customers.
- To assist in maintaining a proactive quality culture throughout the organisation and assist quality activities to achieve the standards of excellence as set out in the company’s quality and environmental policies.
- Other duties as requested by Senior Management.
- Be prepared to undertake any internal / external training as required.
- To implement the Company’s Quality Policy as documented in the Quality and Procedures Manual.
- You will behave in a professional manner at all times and you will build professional relationships with customers that will enhance the Company’s quality image.
- Degree in Life Sciences, Pharmaceuticals, Engineering or related subject
- Proven Regulatory and Quality Assurance experience from medical devices/pharmaceutical field
- Ability to demonstrate Regulatory knowledge (MDD) in Class I and Class IIa devices as a minimum
- Hands on experience of creating and maintaining technical files in accordance to MDD/MDR
- Experience of working with ISO 13485 and ISO 14971
- Experience of dealing directly with Notified Bodies and Competent Authorities such as MHRA
- Strong analytical and problems solving skills
- Quick learner with a “can do” attitude
- Able to demonstrate pro-activity
- Ability to work on own initiative as well as in a team
- Good IT and communication skills
- Experience of creating Clinical Evaluation Reports in accordance with MDD/MDR
- Internal auditing experience
- Experience of dealing with Post Market Surveillance
- Experience of auditing to ISO 13485/ISO 9001
Salary - £28k - £35k
Contributory Pension Scheme
Private Health Care
Life Assurance Subsidised staff canteen
Free on-site car parking
Job Ref: 6131