Quality and Regulatory Manager

Overview

Our Client, a well established Medical Devices company based on the South Coast are looking for an experienced QA/RA Manager to head up a talented team consisting of a Senior Quality Engineer, a Regulatory Specialist, Technical Author, a QC Inspector and a couple of rising star Graduates as the company Manufacture Class IIa and IIb products to UK and EU MDR standards.

Ideally you will have a good blend of QA and RA experience as well as strong people leadership skills. You will be responsible for helping to maintain the company's Quality Management System and the regulatory compliance of the product range. With a lot of the work being undertaken at the moment involving the MDR, experience somewhat weighted towards Regulartory Affairs will be required as you will have hands on involvement in aspects such as Clinical Evaluations.

Benefits

• 25 days annual leave plus bank holidays
• Cycle2work scheme
• Money back on everyday health costs including optical, dental and other therapies
• Training and development support
• Retail and health club discounts
• Access to a 24-hour advice and Information line for you and your family covering legal,
• health and wellbeing advice
• Life Assurance
• Company sick pay scheme
• Hybrid working

Responsibilities

• Leadership and management of all quality and regulatory related issues
• Ensuring that processes needed for the quality management system are documented
• Reporting to top management on the effectiveness of the quality management system and any need for improvement
• Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisation.
• Provide coaching, mentoring, and leadership to the plant Quality and Regulatory staff
• Lead and own the plant Management Review process
• Lead the site's quality improvement process; including data analysis, CAPA, improvement projects, and process capability to improve key metrics.
• Manage the establishment and maintenance of Technical Files for the Companies products and issue of Declarations of Conformity for those products in connection with compliance with the UKCA and EU CE marking and technical file review and update to meet the UK medical regulations and EU MDR requirements and then ongoing maintenance
• Take the roles of Management Representative and Person Responsible for Regulatory Compliance
• Manage product registration, including new product registrations in international markets.
• Manage the transfer of new product development projects into Production, including GSPR generation, risk management, Hazard, Clinical Evaluation etc and the tracking and communication of product performance against established metrics during the post launch period.
• Participate in the Copy Approvals process
• Manage the Post Market Surveillance process.
• Manage the Supplier Approval process
• Manage the preparation and activities for Notified Body audits and follow up
• Assist with the Complaint and Vigilance management
• Manage the completion of standards reviews
• Perform Internal and Supplier audits as necessary, including VM suppliers
• Management of the Engineering Change process
• Assist the management team to achieve their Environmental objectives, ensure compliance with Regulations such as WEEE, RoHS, REACH and battery directive etc

Qualifications/Experience

• Either a Degree or equivalent in Mechanical Engineering, Electrical Engineering, or similar engineering field or in other pertinent science or technical field or, 5 - 10 yrs experience in a Manufacturing, Engineering, or Quality/Continuous Improvement environment.
• Experience with supervision of technical and regulatory professionals is highly desirable
• Proven leadership ability to manage a team, make decisions and deliver results
• Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis
• Knowledge of UK, European and Global Regulatory requirements. (Medical Device Regulation, MHRA, MDSAP, FDA, WEEE, RoHS etc)
• Working knowledge of ISO 9001, ISO 13485, and MDD / MDR
• Ability to set goals and meet project deadlines
• Effective communication skills, both oral and written are required
• Experience with Class III or significant Class II devices

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.