Summary: The role of QARA Consultant involves ensuring compliance with industry regulations and standards for a medical device business. The position requires collaboration with various teams to maintain product quality and safety while navigating regulatory submissions. Candidates should have substantial experience in regulatory affairs and quality assurance within the medical device sector. This role offers a hybrid working model and the opportunity to work with diverse medical device companies.

Key Responsibilities:

• Ensure compliance with industry regulations and standards in line with client requirements.
• Develop and implement quality assurance processes.
• Conduct audits (stage 1 and 2) to assess adherence to quality standards.
• Provide guidance on regulatory requirements.
• Collaborate with teams to maintain product quality and safety.
• Navigate regulatory submissions for products.
• Stay updated on evolving regulatory requirements.
• Assist in resolving compliance issues and implementing corrective actions.

Key Skills:

• A degree in medical engineering or a life sciences subject.
• Lead auditor qualification.
• Experience working in the medical device sector.
• Proven experience in managing clinical evaluations, technical file creation, and risk management.
• Experience working to ISO13485.
• 5+ years of experience in regulatory affairs and quality assurance.

Salary (Rate): undetermined

City: undetermined

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other