Regulatory Lead, Medical Devices - Cambridgeshire, United Kingdom - The One Group

The One Group

Verified Company

Cambridgeshire, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

New

Location: Cambridgeshire
Salary: Negotiable per year
Job Type:Permanent

Posted about 2 hours ago
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Sector: Technical & Engineering Recruitment

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Contact: Jen Richardson

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Expiry Date: 14 May 2023

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Job Ref: BBBH46938_

The ONE Group have been partnering with this company for a number of years and have always been impressed that a relatively small company could do such BIG things with medical devices

Based in pretty, rural Cambridgeshire, on the A1 corridor, not far from St Neots, this organisation are specialists in remote health and well-being monitoring, via a sleek wearable device and associated software.

Another part of the business provides innovative preventative oral care and infection control technologies. A real mix of Class 1 and Class 2a medical devices

Due to company growth, the
Regulatory Lead will manage compliance across the company's portfolio. This will be a varied position working across several different product ranges with varying customers and standards.

Initially there will be an element of QMS Management and ensuring ISO:13485 standards are adhered to. However, the role will evolve over time and be completely focused on regulatory compliance.

The Role:

Lead the company's Regulatory Affairs and Quality Assurance function and strategy, including product registration, complaint handling & reporting and internal and external audits
Be the operational medical device regulatory affairs "goto" person for the company, providing advice to other departments
Coordinate inspection of the organisation and contract facilities and develop procedures to ensure regulatory compliance
Ensure compliance with regulations set by MHRA
Plan, undertake and oversee trials and regulatory inspections
Outline requirements for labelling, storage and packaging
Develop, review, update and implement regulatory strategy
Risk assessments
Provide a high level of customer service as first point of contact with externals on technical queries, complaints, recalls/FSCA, vigilance including postmarketing surveillance and quality issues for medical devices and pharmaceuticals

About You:

Degree in a scientific or related field
Significant proven leadership experience of Regulatory Affairs within the medical devices and pharma industry
Extensive knowledge of regulatory requirements (MDD, MDR)
Ability to independently develop regulatory strategies
QA/RA experience in a regulated environment (e.g., ISO 13485:2016)
Ability to drive standards

The position is most likely to be based on-site, although there may be the opportunity for some remote work and flexibility.

Hours are 9am to 5pm Monday to Friday.

Holiday starts at 20 days per year, rising to 23 days after 2 years and 25 days after 3 years.

There is a generous company pension scheme. This is a small company where many of the team have worked for years. Salary will be dependent on your experience and what you can offer the role and organisation.

Looking forward to hearing from you