Quality Assurance and Regulatory Affairs Manager
An exciting opportunity has arisen within the Pillans Group working at Q Medical Technologies Ltd. Head office is based in Endmoor, however remote working could be considered for this role. The position will be full time 8.30am – 17.00pm, Monday to Friday.
Candidate profile:
Excellent interpersonal skills, you will be confident and able to communicate at all levels and have experience of team-working and working under pressure.
Required Competencies:
- Project Management
- ISO Management & Compilation
- Quality and Regulatory Assurance Experience
- ISO13485:2016 Experience
- CE Trained
- Technical file writing
- Internal audit lead experience
- Risk Management 14971 experience
- MDR Compliance experience and knowledge
Preferred but not essential:
- Biocompatibility
- Clinical Trial Experience
What we offer
- Competitive salary to be discussed depending on experience £40,000+
- Company pension contribution
- 25 days holiday plus bank holidays
- Life assurance
- Health insurance
Key Responsibilities
- Manage and review quality systems to improve awareness, visibility, and communication on quality goals
- Managing quality requirements for the business
- Accountability for monitoring and maintenance of existing processes
- Accountable for internal and external audits
- Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
- Managing the execution of Notified Body audits and track progress of responses
- Accountable for investigating quality issues and interacting with products suppliers
- Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
- Authorising product release to stock and completion of relevant records upon receipt
- Managing risk throughout Q Medical Technologies Ltd
- Ensuring effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance
- Managing new product registration, in line with commercial objectives
- Writing technical files with the QARA Director
- Organising clinical trials for new projects
- Develop project proposal as required by the QARA Director
- Supporting national tender account meetings
- Working with the senior management team, representing head office
- Supporting project managers with ongoing company projects Managing budgets for Q Medical.
- Managing supplier meetings and contracts for Q Medical.
