Quality and Regulatory Affairs Manager Job in Alloa FK10 2HU, Central Scotland UK
Qualification/Experience:
Degree (or equivalent level) in a life science or engineering subject with several years experience of working within the quality and regulatory functions of medical devices or life science industry
Skills:
The successful individual should be able to demonstrate the following skills:
· Developing quality and worldwide regulatory strategies
· Managing and coordinating the preparation, submission and maintenance of regulatory documents and providing regulatory support
· Quality Auditing
· Excellent communication and interpersonal skills
· Effective oral and written communication skills
· Excellent organisational and planning skills
· Attention to detail
· Self-starter
· Proactive, takes initiative and can work alone or in a group.
· Can manage and meet required commitments and deadlines.
· Can effectively manage multiple projects at one time.
· Occasional travelling may be necessary
Position Summary:
The post entails consulting on quality and regulatory affairs, primarily in the medical devices industry.
The successful individual will be expected to provide expertise in matters relating to quality and regulatory compliance:
· ISO9001/ISO13485 Quality Management Systems – managing, implementing and maintaining.
· Internal and external audits
· CE Marking - Design Dossiers and Technical Files
· FDA QSR, IDEs, PMAs, 510ks
· Canadian Device License Applications
· Medical Device Vigilance and reporting
· Clinical Requirements
· Risk Management
· Liaise with Regulatory Authorities
· Provide regulatory advice on the regulatory environment, laws, standards, guidance documents and policies worldwide
· Provision of training and support relating to quality and regulatory matters
· Enhance visibility, expertise and credibility of the company
· Ensure customer regulatory needs are met according to contract, in an accurate and timely manner.