Medical Device Regulatory jobs

Job Description

Regulatory Affairs Coordinator Jobs in Andover at Stannah - Join Our Team!

Stannah have an exciting opportunity for a Regulatory Affairs Coordinator to join the Regulatory Affairs team based at our Andover Head Office.

This role will involve supporting the Head of Regulatory Affairs to ensure Stannah products comply with relevant legal, regulatory and internal policy requirements. You'll play a key role in maintaining regulatory records, coordinating testing and certification activities, supporting compliance initiatives and helping to ensure our product documentation remains accurate and up to date.

As the Regulatory Affairs Coordinator, you will work full-time hours on a permanent basis. The successful candidate can work on a hybrid basis after successful training with flexi-time working.

This is a great opportunity for someone looking to build a career in regulatory affairs, compliance or quality within a global manufacturing business. With structured training and development provided, this role offers an excellent foundation for candidates with strong administration, organisation and attention to detail skills who are keen to develop specialist regulatory knowledge.

To be successful as the Regulatory Affairs Coordinator, it is essential that you have strong organisational skills and attention to detail. Experience of Document Control within a manufacturing environment, ideally Medical Device manufacturing, would be highly desirable, as is knowledge of CE Marking. This is not a straightforward admin role, you will be working on multiple regulatory projects, and over time, it is expected that you will become familiar with various regulations and be comfortable working with them. A willingness to learn is a prerequisite.

Regulatory Affairs Coordinator Responsibilities:

• Maintain and organise regulatory records, technical files, Declarations of Conformity and certification documentation.
• Support the creation, implementation and maintenance of regulatory processes, registers and tracking systems.
• Gather, collate and verify data for regulatory filings, registrations and compliance reporting.
• Coordinate testing and certification activities with external laboratories and certification bodies.
• Assist with regulatory monitoring, compliance training administration, audits and stakeholder communications.

Please see the full job description here: Regulatory Affairs Coordinator

Qualifications

Regulatory Affairs Coordinator Requirements:

• Strong organisational skills with excellent attention to detail.
• Good written and verbal communication skills and proficiency in Microsoft Office applications.
• Ability to manage multiple priorities, maintain accurate records and meet deadlines.
• A proactive approach with a willingness to learn and develop knowledge of regulatory compliance and product legislation.

If you have previous experience working as a Regulatory Affairs Coordinator, Compliance Administrator, Quality Administrator, Technical Administrator, Document Control Coordinator or in a similar role and are looking for a Regulatory Affairs Coordinator job in Andover, please click the "Apply Now" button or contact us for further information.

Additional Information

Benefits Include:

• Market Aligned Salary, paid on a monthly basis
• Profit Share Bonus Scheme, paid to all employees every quarter. Based on Group Company profits
• 25 days holiday, plus bank holidays
• Holiday scheme to buy extra days’ annual leave
• Pension Scheme. Matched contribution/salary sacrifice
• SimplyHealth Cash Plan. Allows you to claim towards health costs. For example, dental, optical, physiotherapy, chiropody treatments and more
• Life Assurance Scheme
• Long Service award scheme, with holiday benefit
• Company Benefits Discount Rewards Scheme. Includes shop discounts, hotel discounts, days out, and more
• Employee Assistance Programme. A workplace initiative to support and enhance well-being
• Enhanced maternity and paternity provision
• Free parking

#HA

Stannah Group is an equal opportunities employer. We welcome and encourage applications from candidates of all backgrounds, identities, and abilities.

We are a Disability Confident Committed Employer. We treat all our job applicants fairly and with respect. Our employees are the heart of our business.

We take great care to create a working environment where everyone feels valued. Join our team and be a part of our diverse and inclusive community!

We reserve the right to close this vacancy early if we receive high numbers of applications for the role.

Appropriate right to work must be held by applicants. Sponsorship is not available.