Regulatory Affairs Specialist

Randstad; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading recruitment agency is seeking a Principal Regulatory Affairs Associate to ensure medical devices meet regulatory requirements for market access. This role involves representing Regulatory Affairs on product development teams and authoring EU technical documentation for global submissions. Candidates should have experience in Regulatory Affairs within the medical device industry, particularly with EU and US regulations, and possess strong communication and analytical skills.

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• Experience in Regulatory Affairs within medical devices or IVD industry.
• Strong understanding of EU and US regulations.

Responsibilities

• Support product development teams on regulatory compliance.
• Author EU technical documentation and global regulatory filings.
• Review design control documentation for regulation compliance.

Skills

Regulatory Affairs experience

Communication skills

Analytical skills

Project management

Proficiency in Microsoft Office

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job Title : Principal Regulatory Affairs Associate

Location : Remote

Contract length : 12 months

Pay rate : Flexible

Job Summary

The Principal Regulatory Affairs Associate will play a pivotal role in ensuring our clients medical devices meet all applicable regulatory requirements for market access and post-market compliance. This individual will be a key contributor to regulatory strategy, submissions, and ongoing lifecycle management.

Job Responsibilities

• Represent Regulatory Affairs on product development teams to support new product development and change control, ensuring compliance with US, EU, and other global regulatory requirements.
• Author EU technical documentation under MDR, FDA submissions (e.g., 510(k)) and other global regulatory filings.
• Evaluate medical device regulations and lead the development of global regulatory strategies to bring products to market.
• Review and approve design control documentation in consideration of US, EU, and other global regulatory requirements.
• Develop and implement global regulatory strategies for assigned product portfolios, ensuring alignment with business objectives and compliance with relevant regulations.
• Act as a primary regulatory liaison with internal teams (R&D, Quality, Marketing, Clinical Affairs).
• Provide expert regulatory guidance and interpretation of regulations, standards, and guidance documents to cross-functional project teams throughout the product lifecycle.
• Monitor and assess changes in global regulatory landscapes, evaluating their impact on products and processes, and developing strategies to address them.
• Participate in and / or lead regulatory reviews of product labeling, promotional materials, and marketing claims to ensure compliance.
• Contribute to the development and improvement of internal regulatory procedures and processes.
• Mentor and provide guidance to regulatory affairs associates as required.
• Participate in internal and external audits as a regulatory subject matter expert.

Required Skills & Experience

• Bachelor's degree in a scientific discipline or equivalent relevant experience.
• Experience in Regulatory Affairs within the medical device or IVD industry, with a strong emphasis on EU and US regulations.
• Demonstrated experience in leading complex regulatory submissions (e.g., CE Mark, 510k, PMA, Q-Sub) and other global regulatory agencies.
• Strong understanding of relevant international standards (e.g., ISO 13485, ISO 14971, IEC 62304).
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly and concisely to diverse audiences.
• Proven ability to work independently, manage multiple projects simultaneously, and meet tight deadlines.
• Strong analytical, problem-solving skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work effectively in a global, matrixed organization.