Head of Quality & Regulatory Affairs

Recruiter
G2 Clinical & Professional Resourcing
Location
Reading
Salary
£60,000 - £70,000 + benefits
Posted
03 Dec 2017
Closes
08 Dec 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Title: Head of Quality & Regulatory Affairs

Salary + OTE: Circa £70,000 - £80,000 + benefits

Location: South UK Southampton - Portsmouth - Bournemouth - Basingstoke

QA RA Professional Medical Devices

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The Role:

I have a rare opportunity to join a young dynamic company developing specialist products for use within the field of fertility.

The Head of Regulatory Affairs and Quality is responsible for managing all regulatory submissiosn and regulatory compliance activities, and for setting regulatory strategies and managing tactics for European Regulatory Affairs, all quality systems. This position reports directly to the CEO

The Candidate

We are looking for an experienced QA/RA professional with a lot of hands on experience. You will have relevant Medical Advice regulatory experience, including business integration and strategy. An excellent understanding of the European Medical Device regulatory affairs environment: regulations; submissions; technical files; cGMP/Quality Systems, Compliance and import/export regulations.

You will have also built and maintained a QMS.

Additionally you will have direct experience in communicating with Regulatory Authorities and Distributors. Global/International regulatory affairs experience and background. Experience with common continuous improvement tools a plus (e.g., six sigma, SPC).

Cultural fit: "down to earth" personality, approachable, friendly with people at all levels and in all cultures, informal, unquestioned integrity, honesty, and a good sense of humor; hard-working and intense; open, collaborative management style that fosters the development of key talent and leaders

G2 Clinical and Professional Resourcing are specialist recruiters for a wide range of positions including R&D, Quality, Compliance, Regulatory Affairs, Manufacturing and Operational positions. sales executives, sales representatives, account managers, medical marketing, business development managers, medical sales, healthcare sales, medical equipment, medical devices, disposables, surgical tools, ophthalmic products, capital equipment, ultrasound, wound care, endoscopy, anaesthetic, cardiovascular, dental, pressure care, mobility equipment, urology, sutures, consumer healthcare, respiratory, infusion, optical, trauma, orthopaedic sales, sports medicine,