Quality Assurance and Regulatory Affairs Manager
- Job Reference: AS/TON/QARAM
- Date Posted: 19 July 2022
- Recruiter: KHR - Recruitment Specialists
- Location: Tonbridge, Kent
- Salary: On Application
- Bonus/Benefits: Great + Company Benefits + Bonus
- Sector: Manufacturing
- Job Type: Permanent
- Work Hours: Full Time
Role: Quality Assurance and Regulatory Affairs Manager
Salary: £50,000 - 55,000 per annum + Company Benefits
Our client, a rapidly expanding manufacturer with an excellent reputation for high-quality goods, is looking to recruit an experienced and enthusiastic quality professional to lead their Quality Assurance and Regulatory Affairs Manager on a permanent basis. This is an important and responsible role and for the right candidate, would provide a very rewarding challenge.
The position would have overall responsibility for the site's quality management system and for compliance with the required regulatory standards for their industry. You will also have responsibility for overseeing technical files to ensure they comply with industry regulations. Experience and an understanding of the requirements of ISO 13485, MDR/MDD, FDA 21 CFR 820, and cGMP would be strongly desirable and advantageous.
Your role will include:
- A key area of the role would be to take the lead in quality and regulatory audits and work closely with external audit bodies and competent authorities to demonstrate the company's compliance. - - - You would also head up the QMS management review on an annual basis.
- You would take the lead in ensuring a successful transition from EU MDD to EU MDR requirements and would need to manage associated deadlines with this project, whilst ensuring full compliance with UK MDR requirements (and UKCA once the regulation is published).
- You will take charge of the CAPA process and be responsible for the investigation of customer complaints, non-conformities, and quality defects.
- You will also provide the final batch release sign-off required for all products leaving our manufacturing site.
- Oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.
- Ensure that the quality management system fully supports the current and future commercial needs of the business.
- Manage the Regulatory team to ensure that all aspects of compliance are achieved.
- Ensure complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
- Ensure effective data management systems and programmes to provide assurances of regulatory compliance whilst providing for a high level of internal and external customer satisfaction.
- Remain up to date with impending changes and developments regarding regulatory and compliance requirements.
- Ensure that the company's technical files are compliant with the relevant regulations (in conjunction with the Research and Technology Manager).
- Provide sound advice to management on regulatory requirements for the development of new products.
- Liaise with the company's notified body / competent authority as and when required.
- Collaborate with the Regulatory Affairs personnel from customers, providing assistance for the maintenance of product registrations & technical files.
What we are looking for:
- Excellent oral, written, and cross-functional communication skills.
- Experience in dealing with Notified bodies or competent authorities.
- Ability to prioritise and make decisions, whilst showing good problem-solving ability.
- Positive attitude toward change and contribution to new ideas/ways of working.
- Strong organisational and team-working skills including commitment and flexibility.
- Excellent attention to detail.
- Sound work ethics.
Experience and Qualifications:
- Degree educated or equivalent, in a life science or engineering discipline.
- A minimum of 5 years experience in a medical device regulatory environment
- An in-depth knowledge and appreciation of the regulatory requirements including technical files for placing class I & II medical devices on the European market.
- Experience in other markets (North America, Asia-Pacific markets) would be desirable.
- Strong Knowledge of the Medical Device Directive (MDD) and Medical Device Regulations (MDR)
- Experience and an understanding of the requirements of ISO 13485, MDR/MDD, FDA 21 CFR 820, and cGMP would be strongly desirable and advantageous.
- Competitive Salary
- Private Healthcare
- A holiday allowance of 26 days per year + Bank Holidays Holiday
- 7% Company Contribution
- Discretionary bonuses on performance and attendance
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