Quality And Regulatory Manager - Advanced Wound Care Dressings, Absorbents, Skin Protectants

​​​The Company: 

• Year on Year growth. 

• Great career opportunity. 

• Part of a larger group.  

• Established for over 25 years. 

 

Benefits of the Quality And Regulatory Manager 

• £65k-£75k  

• Pension  

• Private healthcare  

• Mobile  

• Laptop  

• 25 days’ annual leave + bank holiday 

 

The Role of the Quality And Regulatory Manager 

• Our client sells a range of advanced wound care dressings, absorbents, skin protectants, peak flow meters, gloves, & surgical tapes.  

• The QA/RA Manager will be responsible for ensuring continued compliance of the Company’s Quality Management System with the relevant Medical Device Directives, Medical Device Regulations, International Standards, and Customer Requirements and provide knowledge and support to the company to enable it to operate within all the applicable Regulatory Guidelines.  

• The QA/RA Manager will act as the person responsible for regulatory compliance within the definition of the EUMDR 2017/745. 

• Lead and mentor the QA team: Manage, train, and develop the QA/RA team, including hiring, performance reviews, and fostering a collaborative, results-driven environment. 

• Allocate resources: efficiently manage the team's workload, budget, and resources to meet project timelines and quality goals. Maintain frequent contact with external sub-contract manufacturers and suppliers.  

• Ensuring that process validations and other activities are in a state of control. 

• Resolving quality issues. 

• Identify issues and minimise regulatory risks.  

• Promote a quality culture within the organisation.  

• Maintain a personal knowledge of the current Quality Management System and applicable Regulatory Requirements.  

• Managing a team of 3.  

 

The Ideal Person for the Quality And Regulatory Manager 

• The QA/RA Manager will have a tertiary qualification in life sciences or engineering (BSc, or BEng).

• The QA /RA manager will have a minimum of 4 years of experience in a regulatory compliance role in the medical device industry.

• Ideally experience of managing a small team. 

• Specific experience in regulatory affairs and submissions in the UK, European Canadian and American markets is required. 

• Experience in dermatology products is desirable. 

• Qualification or experience as a microbiologist is desirable. 

 

If you think the role of Quality And Regulatory Manager is for you, apply now! 

 

Consultant: Rio Barclay 

Email: riob@otrsales.co.uk 

Tel no. 0208 397 4114 

Candidates must be eligible to work and live in the UK. 

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