Quality & Regulatory Manager

On Target Recruitment Ltd; City Of London; On-site; GBP 65,000 - 75,000; Full time

Job summary

A recruitment agency is seeking a Quality And Regulatory Manager to lead the QA team and ensure compliance with medical device regulations. The ideal candidate has a relevant degree and over 4 years of regulatory experience, particularly in the medical device sector. This role offers a salary range of £65k-£75k, along with benefits such as private healthcare and annual leave.

Benefits

Pension

Private healthcare

Mobile

Laptop

25 days annual leave + bank holiday

Qualifications

• Minimum 4 years of experience in a regulatory compliance role in the medical device industry.
• Experience managing a small team.
• Specific experience in regulatory affairs and submissions in the UK and international markets.

Responsibilities

• Lead and mentor the QA team.
• Allocate resources and manage the team's workload.
• Maintain contact with external manufacturers and suppliers.
• Resolve quality issues and promote a quality culture.

Skills

Regulatory compliance

Team management

Problem-solving

Knowledge of medical devices

Education

BSc or BEng in life sciences or engineering

Job description

About the Company

Year on Year growth. Great career opportunity. Part of a larger group. Established for over 25 years.

Benefits

• £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.

Act as regulatory compliance person under EUMDR 2017/745.

Responsibilities

• Lead and mentor the QA team; manage, train, and develop the QA/RA team, including hiring, performance reviews, and foster 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.
• Ensure process validations and other activities are in a state of control.
• Resolve quality issues.
• Identify issues and minimise regulatory risks.
• Promote a quality culture within the organisation.
• Maintain personal knowledge of current Quality Management System and applicable Regulatory Requirements.
• Managing a team of 3.

Qualifications

• Tertiary qualification in life sciences or engineering (BSc or BEng).
• Minimum 4 years of experience in a regulatory compliance role in the medical device industry.
• Experience 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.

Apply

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

Consultant: Rio Barclay

Email: (url removed)

Tel no. (phone number removed)

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

About On Target

At On Target, we specialise in sales, technical and commercial jobs in the Engineering, Construction, Building Services, Medical & Scientific, and Commercial & Industrial Solutions sectors, enabling our consultants to become experts in their market sector. We place all levels of personnel, up to Director across the UK and internationally.