Medical Device Regulatory Affairs jobs

Benefits highlight:

• Employee-Owned Business
• BCorp
• Enhanced Employee Pension contributions
• Private Health Cash Plan
• Paid volunteer days

Overview:

Are you a hands-on Quality Assurance and Regulatory Affairs professional looking to put your skills and efforts into an ethical and environmentally positive company that is a BCorp and owned by its employees?

There’s never been a more exciting moment to join Natracare (Bodywise UK Ltd). As we transition into an Employee Ownership Trust (EOT), we’re investing in our future, growing our team, strengthening what has always made us exceptional, and building the foundations for long term, shared success.

For over 37 years, we’ve been pioneers and global leaders in certified organic and natural period and personal care. We’ve championed health, environmental responsibility, equity, and human rights across our sector.

Our QMS is mature, well established and highly regarded. With medical device ISO 13485 certification since 2004, MDSAP certification since 2021 and numerous organic and ecological certifications holding third party validations, scrupulously maintained over several decades. As a campaigning and ethically valued company, we design and produce products to the highest standards as well as having representation to help improve standards, to continuously move the categories forward to solve problems for the health of people and planet.

We are looking for an experienced person who will lead regulatory activities, maintain quality systems, plan and carry out internal audits, maintain technical documentation; but to also drive continuous improvement.

Working in a small established team, this role is ideal for someone who gets excited about quality objectives and regulatory rigour, and thrives on detail-oriented challenges.

Key Responsibilities

• Partake in, and manage, regulatory compliance activities, including preparation and submission of regulatory filings, reports, and registrations, as appropriate, aligned with ISO 13485:2016; Canadian MDR; FDA – 21 CFR for class II and class I (low risk) medical devices.
• Partake in, and manage, regulatory compliance activities, including the preparation and submission of regulatory filings, as appropriate, reports and registrations for class I medical devices EU MDR.
• Prepare, lead, and manage regulatory submissions and communications with authorities and other relevant standards, as appropriate.
• Maintain DMR and all quality technical files.
• Support Notified Body external audits to maintain ISO13485 and MDSAP certifications.
• Support Notified Body external audits to maintain organic and environmental certifications.
• Plan and carry out internal audits to verify compliance of internal processes.
• Maintain and update SOPs, ensuring alignment with company practices and regulatory requirements.
• Management of non-conformances, CAPAs, and process improvements.
• Design and deliver interactive SOP training where appropriate.
• Evaluate and monitor critical suppliers, maintaining their approval and validity.
• Keep up to date and share key regulatory changes internally
• Carry out additional quality-related activities as required
• Keep an ear to the ground for upcoming changes, risks and opportunities

Standards & Regulations you will work with

• ISO 13485
• ISO 14971
• ISO 14024 (Global Organic Textiles Standard, Nordic Ecolabel and EPD)
• EN 13482
• COSMOS Organic and Natural standards

About You

Able to enthuse and communicate the importance of quality management, be methodical and fastidious about details, and help preserve team integrity. Your skills and experience will include:

• Appropriate Bachelor’s degree that comes with an ability to analyse, differentiate and categorise risk, and produce eloquent documentation.
• Minimum 5 years’ experience working in Quality Assurance and Regulatory Affairs, ISO 13485 within Class II and Class I medical devices.
• Able to take initiative and work effectively to deadlines as well as knowing when to escalate or seek guidance
• Flexible and adaptable, with a positive approach to hybrid working and team contribution
• IT literate with ability to pick up new systems with ease. You will need an ability to assimilate and interpret organic and ecological standards which are also applicable to our company and products.

More reasons to choose us

As an employee-owned business, we believe success is something to be shared. That’s why every member of our team has a genuine voice in how we work and where we’re headed. Through our Employee Voice groups, everyone can help shape day‑to‑day decisions, influence our workplace culture, and contribute to the future we’re building together.

Employee ownership also means greater transparency, meaningful involvement, ongoing investment in your learning and development, and a real stake in our long‑term growth.

On completion of one years’ service, all employees are eligible to participate in our annual tax‑free profit share of up to £3,600. And that’s just the beginning, we also offer:

• 27 days annual leave plus bank holidays
• Option to join Private Health Cash Plan
• Free organic fruit, tea, coffee, and milk(s) in the office
• Bike lockups and showers
• Free parking and electric charge points
• Swap up to five office days a year to work remotely anywhere, including abroad
• Two paid volunteering days annually
• Enhanced employer pension contribution – between 5% to 8%
• Enhanced paid maternity leave
• Annual work anniversary gift cards
• Cycle to work scheme
• Electric vehicle salary sacrifice scheme
• Endometriosis Friendly Employer creating a fairer and safer workplace for employees experiencing endometriosis

Job type: Permanent part time, 2 - 3 days a week (ideally in office for 2 days a week but would consider more remote for right candidate)

Location: North Bristol

To apply:

Contractors need not apply

Deadline for applications: Monday 3rd August

We’ll be in touch after the application deadline to arrange an introductory call and interview for next stage candidates. We look forward to hearing from you.

Email us at jobs@natracare.com using the reference “Quality and Regulatory Affairs Manager” as the subject line. Please send a copy of your CV and a cover letter introducing yourself, your interests and how you’re a good fit for the role.

Equal opportunities

It’s our ambition to create an inclusive environment where we can all be ourselves and work together as one united team. We are committed to enabling everyone to thrive, and understanding and celebrating our differences, is a key part of that.

Pay: £50,000.00-£55,000.00 per year

Work Location: Hybrid remote in Bristol BS32 4EU