QA/RA Manager

Description:

Regulatory & Quality Manager (Medical Devices)

About the company
We are a rapidly growing consumer goods company with an established portfolio of Class I medical devices, cosmetics, general products, toys and food supplements. As we scale, we're strengthening our regulatory and quality capabilities to support continued success and innovation.
This is an exciting opportunity for an experienced professional to shape and embed a culture of compliance, designing and leading systems, processes, and teams that ensure our products meet the highest standards of safety and performance.

Role purpose
To lead, develop, and maintain the company's regulatory and quality management systems in alignment with ISO 13485 and 21 CFR 820, ensuring the continued compliance of the company's Class I medical device portfolio across geographies.
This role combines strategic regulatory leadership, hands on quality system management, and people development, driving excellence in product compliance, market access, and post-market performance. The successful candidate will build and inspire a high-performing, distributed team while shaping a proactive, values driven culture of quality and compliance across the organisation.

Key Responsibilities
Quality Management System (QMS)

Embed QMS to achieve and sustain compliance with ISO 13485 and 21 CFR Part 820.
Lead the implementation and continuous improvement of a digital EQMS solution.
Oversee document control, CAPA, supplier management, change control, complaints, and risk management processes.
Prepare for and lead internal and external audits, ensuring year-round audit readiness.
Promote a "right first time" quality mindset across teams.Regulatory Affairs

Maintain compliance and technical documentation for the company's Class I medical device portfolio.
Lead regulatory submissions, renewals, and notifications for relevant markets.
Act as the main point of contact for competent authorities, notified bodies, and regulatory partners.
Stay current with evolving regulations (EU MDR, UK MDR, FDA, etc.) and proactively adapt internal systems.
Oversee vigilance and post-market surveillance activities, driving timely investigation and resolution.Leadership & People Development

Lead, mentor, and develop a small and remote team of quality and regulatory professionals.
Establish clear goals, provide coaching, and foster an environment of accountability, collaboration, and growth.
Promote continuous learning and professional development within the team.
Influence stakeholders across R&D, Operations, Supply Chain, and Commercial to embed compliance principles early in the product lifecycle.
Act as a trusted advisor to senior management on quality and regulatory matters.Qualifications & Requirements

Degree in a scientific, engineering, or regulatory discipline (or equivalent experience).
7+ years' experience in regulatory and/or quality roles within the medical device industry, ideally including Class I devices.
Demonstrated experience implementing or improving QMS frameworks to ISO 13485 and/or 21 CFR 820.
Experience managing teams including coaching and developing remote or hybrid team members.
Solid knowledge of risk management (ISO 14971), post-market surveillance, and audit management.
Excellent written and verbal communication skills.
Desirable but not essential: experience in general products, toys and/or food supplements

Key Attributes

Strategic, hands-on leader with a collaborative and empowering management style.
Skilled communicator who can build alignment and motivate dispersed teams.
Commercially aware, with a pragmatic approach to compliance.
Passionate about developing people and embedding a strong, values-driven quality culture.
Work Environment & Benefits

Competitive salary and performance based incentives.
Comprehensive insurance.
Pension scheme with employer contributions.
Hybrid work option [Monday, Wednesday, Thursday in Office, rest Remote].
Inclusive and dynamic work culture with opportunities for career growth.Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy