Remote Regulatory Affairs Specialist – Medical Devices

ConvaTec Group; Manchester; Hybrid; GBP 40,000 - GBP 60,000; Full time

Job summary

A global medical solutions company in Manchester is seeking a Regulatory Affairs Specialist to ensure compliance for medical products. Responsibilities include writing regulatory submissions, leading assessments for product changes, and managing global regulatory projects. Open to applicants with relevant experience in the medical device sector and strong analytical skills. This position offers a blend of remote work with occasional office visits and the chance to contribute to significant advancements in medical technology.

Benefits

Competitive salary

Remote work flexibility

Professional development opportunities

Qualifications

• 1-2 years relevant experience in regulatory affairs role.
• Understanding of regulatory framework for medical devices.
• Experience with Class I, II, and III sterile medical devices.

Responsibilities

• Ensure regulatory compliance of Convatec products.
• Write and submit regulatory dossiers, and interface with authorities.
• Lead regulatory assessment and actions for product changes.

Skills

Regulatory compliance

Analytical skills

Interpersonal skills

Problem-solving skills

Time management

Education

Bachelor’s degree in Science, Engineering, Medical Technology, or Nurse

Regulatory Affairs Certification (RAC)

Tools

Microsoft Office (Excel, Word, PowerPoint)

Adobe Acrobat

Documentum

Job description

A global medical solutions company in Manchester is seeking a Regulatory Affairs Specialist to ensure compliance for medical products. Responsibilities include writing regulatory submissions, leading assessments for product changes, and managing global regulatory projects. Open to applicants with relevant experience in the medical device sector and strong analytical skills. This position offers a blend of remote work with occasional office visits and the chance to contribute to significant advancements in medical technology.