Senior Regulatory Affairs Officer

Scienceabode; City of Edinburgh; On-site; GBP 50,000; Full time

Job summary

A leading medical device manufacturer in the Edinburgh area is looking for a Senior Regulatory Affairs Officer. You will manage product licence registrations and collaborate with international regulatory bodies. The ideal candidate has significant experience in the medical device sector, particularly with IVDs, and expertise in CE and FDA regulations. This role offers a competitive salary of £50,000 per annum and numerous opportunities for professional development within a multinational team.

Benefits

Competitive base salary

Opportunities for personal development

Qualifications

• Prior experience in a regulatory role, ideally in an FDA licensed manufacturing facility.
• Significant experience within the medical device sector is essential.
• Expert-level knowledge of CE and FDA regulations, including PMA, BLA, and 510(k).

Responsibilities

• Manage and deliver product licence registration.
• Help build the company's regulatory strategy and ensure compliance.
• Prepare regulatory documentation and submit across US, UK, and EU.

Skills

Regulatory role experience

Excellent communication skills

Knowledge of CE and FDA regulations

Job description

The Role

Senior Regulatory Affairs (RA) Officer – Edinburgh – Medical Devices. SRG are delighted to be working with an internationally renowned medical device manufacturer. As part of continued growth this organisation are looking for a Senior Regulatory Affairs (RA) Officer to join their team in the greater Edinburgh area.

As Senior RA Officer you will work as part of a large, multinational team to help manage and deliver product licence registration, working in collaboration with regulatory bodies across the globe.

As a key part of the RA team you will help build the company\'s regulatory strategy, determine requirements and propose solutions to ensure compliance. On a day-to-day basis this involves the preparation of regulatory documentation and subsequent submission across the US, UK and EU as well as other appropriate territories in line with local guidance.

You will be required to work closely with internal and external stakeholders to ensure all staff and vendors are kept aware of developments and changes in global regulatory requirements. As Senior RA officer you will also be responsible for managing and confirming compliance issues both internally and externally, ensuring all relevant documentation is kept accurate and up-to-date.

The Right Person

• Prior experience in a regulatory role – ideally within an FDA licensed manufacturing facility.
• Significant previous experience within the medical device sector is essential, anyone with prior experience working with IVDs would be preferential.
• Excellent communication skills are essential
• Expert-level knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
• Demonstrable experience supporting regulatory audits and inspections

What\'s in it for you?

This position offers a competitive base salary with a wide array of benefits available. As well as this you will be offered a variety of opportunities for personal development working within a large multi-national team.

Guidant, Carbon60, Lorien & SRG – The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy

£50000/annum

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