Regulatory Specialist
Regulatory Specialist

Regulatory Specialist

Full-Time 36000 - 60000 Β£ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead design control and risk management for medical device development.
  • Company: Join a pioneering team in drug product design and development in Cambridge.
  • Benefits: Enjoy competitive salary, professional growth, and a collaborative work environment.
  • Why this job: Be part of innovative projects that impact healthcare and improve lives.
  • Qualifications: BSc/MSc in relevant science/engineering with 5 years in medical devices or pharmaceuticals.
  • Other info: Willingness to travel and strong communication skills are essential.

The predicted salary is between 36000 - 60000 Β£ per year.

Overview

Benefits: Enhanced training and development opportunities, private health care, volunteer days, flexible start and finish hours, annual bonus, Hybrid working.

SRG is exclusively partnered with a leading manufacturer of personal care products, based in Hampshire. Due to company growth and expansion into new territories, they are now looking for a Global Regulatory Technologist to join the team. This company has a supportive and collaborative culture, and pride themselves on internal progression and development. This role would suit candidates who have 2+ years of experience working with global regulations and compliance across the personal care, skincare, cosmetics or hair care sector.

Working Hours: Monday to Friday 40 hours a week – HYBRID, 33 days holiday

Role/Description:

  • Monitor and stay ahead of formulation ingredient legislation across global markets (UK, EU, FDA & ASEAN)
  • Develop and implement regulatory strategies to support the successful launch products in global markets
  • Oversee packaging, labelling, and artwork approval to meet legal and environmental standards.
  • Review and oversee the creation of PIFs, Dossiers, SDS, CPSR and artwork for new and existing products getting launched in the market
  • Support customers with the claim substantiation across products producing the relevant documentation to support claims on packaging/ artwork
  • Support internal and external teams with regulatory queries
  • Maintain up-to-date compliance documentation and prepare reports for management.
  • Act as the main contact for regulatory bodies, trade associations, audits and external partners.

Requirements:

  • 2+ years of experience working in a regulations or compliance role across the personal care / cosmetics industry
  • Strong understanding of product formulation development and ingredients across the UK, EU, FDA & ASEAN
  • Knowledge and understanding of regulatory process and compliance across PIFs, Dossiers, SDSs, CLP, Reach, CPSC, leaping bunny etc.
  • Experience working with Worldover or similar systems – preferred
  • Must have full right to work in the UK, there is no sponsorship available for this role

Notes: SRG is the UK’s number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It’s this combination that makes us different. We’re committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you would like to apply for this position, please use the link provided. Alternatively, please email a copy of your CV to rhi.turner@srgtalent.com. For more information regarding this position or any others, please call Rhi on 0161 667 1812.

If you have a scientific background and this position is not relevant / suitable for you, please feel free to get in touch or visit www.srgtalent.co.uk to view our other vacancies.

Keywords: regulations, global regulations, UK, EU, FDA, US, ASEAN, CLP, REACH, PETA, Leaping Bunny, SDS, PIFs, dossiers, compliance, regulatory, project management, management, stakeholder management, supplier management, CPSC, formulation, NPD, new product development, formulation, cosmetic ingredients, project management, personal care, cosmetics, skincare, SPF, suncare, FMCG, R&D, Cosmetic Science, cosmeceutical, hair care, lab technician, cosmetic chemist, new product innovation, NPI, innovation.

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Regulatory Specialist employer: SRG

Join our dynamic team in Cambridge, UK, where we prioritise innovation and collaboration in the development of cutting-edge drug-device combination products. As a Regulatory Specialist, you will benefit from a competitive salary and a comprehensive benefits package, while working in a supportive environment that fosters professional growth and development. Our commitment to quality and regulatory excellence ensures that you will play a vital role in shaping the future of healthcare.
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Contact Detail:

SRG Recruiting Team

StudySmarter Expert Advice 🀫

We think this is how you could land Regulatory Specialist

✨Tip Number 1

Familiarise yourself with the specific regulatory standards mentioned in the job description, such as ISO 13485 and ISO 14971. Understanding these standards will not only help you in interviews but also demonstrate your commitment to compliance in design control and risk management.

✨Tip Number 2

Network with professionals in the medical device and pharmaceutical industries. Attend relevant conferences or webinars where you can meet people who work in similar roles. This can provide you with insights into the industry and potentially lead to referrals for the position.

✨Tip Number 3

Prepare to discuss your experience with design validation and risk assessments in detail. Be ready to share specific examples of how you've contributed to these processes in past roles, as this will showcase your expertise and relevance to the position.

✨Tip Number 4

Research StudySmarter and our values, especially regarding innovation in drug-device combination products. Tailoring your conversation during interviews to align with our mission can make a strong impression and show that you're genuinely interested in joining our team.

We think you need these skills to ace Regulatory Specialist

Design Control Expertise
Risk Management Skills
Regulatory Compliance Knowledge
ISO 13485
ISO 14971
21 CFR 820
21 CFR 4
EU MDR
Good Manufacturing Practices (GMP)
Cross-Functional Collaboration
Documentation Management
Design Validation Support
Use-Related Risk Assessments
Excellent Communication Skills
Attention to Detail
Organisational Skills
Project Management
Human Factors / Usability Engineering Familiarity
Device Assembly Knowledge
Internal and External Audit Experience

Some tips for your application 🫑

Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Specialist position. Familiarise yourself with design control and risk management in the context of medical devices and combination products.

Tailor Your CV: Customise your CV to highlight relevant experience in design control, risk management, and regulatory compliance. Emphasise your knowledge of standards like ISO 13485 and 21 CFR 820, as well as any specific projects that align with the job description.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the industry. Mention specific experiences that demonstrate your expertise in regulatory standards and your ability to work collaboratively with cross-functional teams.

Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for this role.

How to prepare for a job interview at SRG

✨Know Your Regulations

Familiarise yourself with key regulatory standards such as ISO 13485, ISO 14971, and 21 CFR 820. Being able to discuss these in detail will demonstrate your expertise and understanding of the compliance landscape.

✨Showcase Your Experience

Prepare specific examples from your past roles that highlight your experience in design control and risk management. Be ready to discuss how you have contributed to design validation activities and supported regulatory submissions.

✨Emphasise Team Collaboration

This role requires working closely with cross-functional teams and external partners. Share examples of how you've successfully collaborated in the past, showcasing your communication skills and ability to manage multiple projects.

✨Prepare for Technical Questions

Expect technical questions related to Good Manufacturing Practices (GMP) and risk assessments. Brush up on your knowledge and be prepared to explain how you would approach various scenarios in the design control process.

Regulatory Specialist
SRG

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