As Regulatory Affairs Specialist for this award-winning Medical Device company you'll be based from the High Wycombe area.
 

• Working as the Regulatory Affairs Specialist in a small, talented team, you'll work with senior management to support the Quality Management Systems (QMS), ensuring compliance to ISO 13485, Medical Device Regulations (MDR), Medical Device Directive (MDD) and other ISO standards. You'll develop and deliver proactive and responsive processes to maintain compliance.
• Day to day creation, management and coordination of technical documentation for medical device regulatory affairs files, including creating written content. Point of contact in relation to sterility, vigilance, product design and risk with support, as required). Ensure timely product release to maintain continuity in the supply chain (sterile / non-sterile medical devices and one medicine). Be the Responsible Person for GDP, MDR Regulatory Compliance and ISO13485.
• Support medical device new product development, investigate and manage technical enquiries and customer complaints, internal auditing, train others on quality management systems (QMS), and more in this varied Quality Assurance Specialist role.

COMPANY

• A well-established and award-winning medical device company ensuring significant improvements to patients' quality of life by providing quality products and outstanding customer care. The company provides excellent employee training and ongoing development opportunities.

REQUIREMENTS

• Proven regulatory affairs experience with medical devices and / or pharmaceuticals, working to Medical Device Directive (MDD) with Class I and IIa devices as well as ISO 13485 and ISO 14971 standards. Experience in dealing with notified bodies and competent bodies, and post market surveillance.
• You must have hands on experience creating and maintaining regulatory affairs technical files in line with Medical Device Directive (MDD) and Medical Device Regulations (MDR) . Experience in creating Clinical Evaluation Reports would be a bonus.
• A degree in a Life Science, Pharmaceutical, Engineering or other relevant discipline, clear communications skills and a team player keen to learn and develop as a Regulatory Affairs Specialist.

PACKAGE

• Salary of £40-45,000 plus great benefits.

Call, email or apply now for full details…