Regulatory & Standards Compliance Specialist

Terumo Aortic; Scotland; On-site; GBP 40,000 - 50,000; Full time

Job summary

A medical device company in Scotland is seeking a Standards Compliance Quality Specialist to enhance quality assurance and regulatory compliance efforts. Responsibilities include monitoring regulations, maintaining compliance throughout the product lifecycle, and providing training on standards. Candidates with a degree in Science/Engineering and knowledge of medical device regulations are encouraged to apply. This position requires strong analytical and problem-solving skills, alongside effective communication in cross-functional teams.

Qualifications

• Degree in Science/Engineering or equivalent background.
• Class III medical device knowledge is desirable.
• In-depth knowledge of medical device regulations and standards.

Responsibilities

• Monitor and evaluate new and revised standards and regulations.
• Review updates to ensure ongoing compliance.
• Maintain compliance throughout the product lifecycle.
• Identify gaps in regulations/standards and coordinate actions.

Skills

Regulations knowledge

Problem-solving

Analytical skills

Communication

Education

Degree in Science/Engineering or equivalent

Tools

QMS tools

Document control systems

Job description

A medical device company in Scotland is seeking a Standards Compliance Quality Specialist to enhance quality assurance and regulatory compliance efforts. Responsibilities include monitoring regulations, maintaining compliance throughout the product lifecycle, and providing training on standards. Candidates with a degree in Science/Engineering and knowledge of medical device regulations are encouraged to apply. This position requires strong analytical and problem-solving skills, alongside effective communication in cross-functional teams.