Regulatory affairs Work, Jobs in Leeds, Eng (with Salaries)

Senior Regulatory Affairs Specialist
Medasil Surgical Ltd —Leeds
- £45,000 - £55,000 a year
- Full-time
- Engineering
- Analysis skills
- Bachelor's degree
Quick apply
3d
REACH Regulatory Consultant
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- Full-time
- Remote
- Doctoral degree
- Business development
- Project management
Data Privacy Senior Executive
BDO —Leeds
- Full-time
- Analysis skills
- Organisational skills
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BDO —Leeds
- Full-time
- Analysis skills
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Senior Regulatory Affairs Specialist

Medasil Surgical Ltd
Leeds

Quick apply

Job details

Full-time
£45,000 - £55,000 a year
3 days ago

Qualifications

Engineering
Quality management
Diagnostic evaluation
Analysis skills
Bachelor's degree
Organisational skills
Communication skills

Full job description

About Us

Medasil Surgical Limited is a leading UK-based medical device company specialising in the design, manufacture, and supply of single-use surgical products. With a strong reputation for quality, and customer focus, we are committed to delivering safe and effective solutions to healthcare professionals worldwide.

The Opportunity

We are looking for a Senior Regulatory Affairs Specialist to join our team in Leeds. This role offers the opportunity to play a key part in maintaining and enhancing regulatory compliance across our product portfolio in a fast-paced and collaborative environment. This is a Full-time position, mainly onsite with occasional flexible working possible.

Key Responsibilities

Ensure compliance with all applicable medical device regulations, standards, and legislation
Create, update, and maintain Technical Documentation and Technical Files
Conduct regular reviews to ensure alignment with harmonised standards and regulatory requirements
Perform regulatory gap analyses against new or updated standards
Review and approve design changes, engineering updates, CAPA, and nonconformances for regulatory impact
Monitor regulatory changes and support updates to SOPs and internal systems
Manage and support product registrations with Competent Authorities (e.g., MHRA, EUDAMED)
Ensure post-market surveillance activities are effectively integrated into Technical Documentation
Review and approve labelling, promotional materials, and product claims
Participate in internal and external audits
Collaborate cross-functionally to support compliant product lifecycle management
Responsible for delivering high-quality, audit-ready technical documentation
Ensuring timely regulatory submissions and approvals
Proactively identifying regulatory risks and recommending solution

Skills & Experience

Minimum 5 years’ experience in a Medical Device Regulatory Affairs role
Bachelor’s degree in Science, Engineering, Regulatory Affairs, or related discipline
Strong understanding of:
MDD 93/42/EEC, MDR 2017/745, and UKCA requirements
ISO 13485 Quality Management Systems

Proven experience in:

Creating and maintaining Technical Documentation
Conducting regulatory gap analyses
Interpreting and applying harmonised standards and regulatory guidance
Reviewing design changes, CAPA, and nonconformances
Post-market surveillance and Technical File maintenance
Knowledge of risk management, clinical evaluation documentation, and labelling requirements
Familiarity with device registration systems such as MHRA and EUDAMED
Strong analytical, organisational, and communication skills

Why Join Medasil?

Be part of a respected and growing medical device company
Work within a collaborative and quality-driven environment
Opportunity to contribute to products that support patient care globally
Career development within Regulatory Affairs
Competitive salary dependent on experience.

Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity

If you are passionate about regulatory compliance and want to grow your career with Medasil Surgical Limited, we would love to hear from you.

Job Type: Full-time

Pay: £45,000.00-£55,000.00 per year

Application question(s):

Do you have experience working with MDD 93/42/EEC and/or MDR 2017/745?
Are you familiar with UKCA regulatory requirements?
Do you have experience creating and maintaining Technical Documentation / Technical Files?
This is full time onsite role in Leeds are you able to work full-time onsite in Leeds?

Education:

Bachelor's (required)

Experience:

Medical Device Regulatory Affairs: 5 years (required)

Work authorisation:

United Kingdom (required)

Work Location: In person

Quick apply

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regulatory affairs jobs in leeds, eng

Senior Regulatory Affairs Specialist

REACH Regulatory Consultant

Data Privacy Senior Executive

Data Privacy Assistant Manager

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