Regulatory Affairs Consultant

Regulatory Affairs Consultant

Port Talbot SA12

Commutable from Swansea, Port Talbot, Bridgend, Pyle, Porthcawl, Neath, Llanelli, Ammanford, 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 exclusively partnered with an expanding medical device business who are looking to acquire a QARA Consultant. This role will provide you with the opportunity to work with a wide variety of medical device businesses ranging from family businesses to multinationals. This role would be well suited to an experienced candidate with experience working in the medical device sector within the field of regulatory affairs completing tasks such as clinical evaluations and risk management.

Role & 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.

Knowledge, Skills & Experience:

• A degree in medical engineering or a life sciences subject will be beneficial, alongside 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.
• Working in a regulatory affairs and quality assurance capacity will be required for this position.
• The successful candidate will ideally have 5+ years of experience.

To apply please email your CV/resume to .

If you are interested in this position please click 'apply'.