Head of Quality Assurance and Regulatory Affairs (7 years experience, £65k, Medical Devices, London)

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Job Description

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We have an exciting opportunity for a Head of Quality Assurance and Regulatory Affairs role in a Medical Equipment Manufacturing company. The company develops smart wearable technology. It's looking for experienced individual who can understand and respond to client needs and difficulties while leading a small, focused team in a fast-paced startup environment.

Job Requirements:

A bachelor's degree in a science or engineering discipline is required.
Extensive expertise in the biotech/medical device industry, with an emphasis on IVD.
Working knowledge of medical equipment classified as Class I and Class II.
Excellent ability to communicate.
7+ years of combined Quality Assurance, Regulatory, and Clinical Affairs expertise.
Experience working in a mid-sized or start-up environment is required.
Established solid working relationships with regulatory agencies.
Capable of organising, prioritising, and executing to meet company objectives.
Knowledge of ISO 13485, MDSAP, IVDR, and GxP regulations.
Basic understanding of software nomenclature, testing, validation, and user requirements, as well as IQ/OQ/PQ.
Considerable experience as the key point of contact for regulatory audits/inspections.
Expert project management abilities are required to develop and implement RA/QA/CA plans.
Cross-functional leadership abilities.

Responsibilities

Job Responsibilities:

Assist Regulatory Affairs, Quality Assurance, and Clinical Affairs teams with high-level strategic leadership.
Collaborate cross-functionally with R&D, Manufacturing, Commercial, and Marketing leaders to provide clinical and regulatory expertise to meet project deadlines.
Develop and lead an engaged team that is innovative, agile, change-receptive, and eager to learn new things in a fast-paced setting.
Professional regulatory and clinical research leadership of all pre-clinical and post-market studies for medical device(s), including research design, clinical monitoring, safety, risk, and feasibility evaluations, site selection, medical compliance, and successful submission execution.
Participate actively in the creation of clinical protocols, investigator brochures, clinical study reports, TMFs, and other important study documentation.
Ensure clinical teams have operational oversight by communicating trial objectives, timetables, and budgets, as well as ensuring correct capacity planning, data processing, and statistical analysis.
Ongoing QMS development, including SOP creation, FDA and GxP compliance, training, management, and audit and certification control.
Maintain solid regulatory compliance, build quality standards, cultivate vendor and external KOL relationships, and assure inspection preparedness at all times to support overall corporate strategy.
SME for QA/RA/CA improvement on a constant basis.
Examine and put all necessary departmental policies, procedures, and trainings into action.
Lead, lead, and develop people while focusing on performance management, fulfilling our values, and succession planning.

Referrals

If you know anyone who may be suitable for the above role, feel free to get in contact with the Mandarin Recruitment team. We will ensure a healthy referral bonus.

About Us

Mandarin Recruitment is a service that helps UK and China businesses & organisations find and source high-quality Mandarin-speaking professionals. We have unparalleled and exclusive channels to the Chinese speaking market, allowing us to be the leading organisation for specialist Mandarin recruitment.