Regulatory Affairs Consultant - Port Talbot - Hunter Selection

Description

Regulatory Affairs Consultant

Port Talbot, a region commutable from Swansea, Port Talbot, Bridgend, Pyle, Porthcawl, Neath, Llanelli, Ammanford, and Cross Hands.

Salary: Negotiable and dependent on experience.

Benefits:

• Standardised pension
• Free parking
• Life Insurance
• 25 days of annual holiday
• Sick pay package
• Hybrid working model

We are partnered with an expanding medical device business seeking a QARA Consultant. This role will involve collaborating with various medical device businesses, including family-run enterprises and multinationals. The ideal candidate will have experience in the medical device sector, specifically in regulatory affairs, completing tasks such as clinical evaluations and risk management.

Key Responsibilities:

• Ensure compliance with industry regulations and standards according to 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.

Requirements:

• A degree in medical engineering or a life sciences subject is beneficial, along with a lead auditor qualification.
• Experience working in the medical device sector is essential.
• Proven experience in managing clinical evaluations, technical file creation, and risk management.
• Proven experience of working to ISO13485.
• The successful candidate will ideally have 5+ years of experience in a regulatory affairs and quality assurance capacity.

Estimated Salary: £50,000 - £70,000 per annum.