Remote Clinical Regulatory Specialist — MedTech Submissions

Welcony; Carmarthen; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A medical technology firm in Carmarthen seeks a Regulatory Affairs Clinical Specialist to ensure compliance with medical device regulations. You will author crucial regulatory documentation, collaborate on clinical trials, and train teams on regulatory requirements. Ideal candidates have an MSc or PhD in Life Sciences and 4-7 years of experience in the medical device industry. This role offers both remote and hybrid work options.

Qualifications

• Minimum 4-7 years of experience in regulatory affairs in the medical device industry.
• Strong experience with clinical evaluation reporting and post-market clinical follow-up documentation.
• Proven experience with FDA, EU MDR, UKCA, and Health Canada submissions.

Responsibilities

• Identify and implement regulatory strategies for medical device compliance.
• Author and maintain Clinical Evaluation Plans and Reports.
• Collaborate with clinical teams to meet regulatory expectations.

Skills

Regulatory strategies for clinical aspects

Technical writing skills

Analytical skills with statistical methods

Project management skills

Collaboration across functional teams

Education

MSc or PhD in Life Sciences

Job description

A medical technology firm in Carmarthen seeks a Regulatory Affairs Clinical Specialist to ensure compliance with medical device regulations. You will author crucial regulatory documentation, collaborate on clinical trials, and train teams on regulatory requirements. Ideal candidates have an MSc or PhD in Life Sciences and 4-7 years of experience in the medical device industry. This role offers both remote and hybrid work options.