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Clinical Compliance Lead

1 month ago

Bracknell, Bracknell Forest, United Kingdom HealthHero Full time

HealthHero, a leading European healthcare provider, seeks an experienced Regulatory Quality Expert to join its Clinical Product Team. This exciting opportunity will challenge you to develop and implement effective quality management systems that meet the evolving needs of our business.

We are seeking a highly skilled individual who possesses in-depth knowledge of quality management and governance within ISO 13485 accredited organizations. As our ideal candidate, you will be responsible for ensuring compliance with regulatory standards, providing guidance on clinical risk management, and developing processes to monitor and report actions resulting from audit reviews.

In this role, you will work closely with cross-functional teams to drive business growth and expansion while maintaining the highest level of quality and safety standards. Your expertise will be invaluable in navigating complex regulations and guidelines, ensuring seamless integration of HealthHero's functions and entities, and preparing for audits and certifications.

Key responsibilities will include:

  • Leading the development and implementation of quality management systems, ensuring proactive engagement with product, technical, and client services teams
  • Servicing as a point of contact for Notified Bodies and other external stakeholders, facilitating Class 1 Medical Devices transitioning to Class 2a under the EU MDR framework
  • Preparing for and participating in ISO 13485 audits, collaborating with the Governance Team to maintain a certified quality management system
  • Evaluating and implementing effective systems for evidence-based Clinical Product performance and clarifying stakeholder responsibilities within product development
  • Auditing key systems, ensuring accurate documentation of processes, training, and support materials
  • Compiling and maintaining QA documentation to support business development, reviewing bid responses, and providing information for applications and diligence activities

You will have the opportunity to develop your skills and experience while working on challenging projects that impact the success of our organization. We offer a dynamic work environment that values collaboration, innovation, and continuous improvement.

**Salary:** £60,000 - £80,000 per annum depending on experience

**Location:** Bracknell office or hybrid remote work arrangement

**Requirements:** Degree-level education, relevant experience in quality management and medical device regulation, excellent communication and problem-solving skills, ability to work independently and collaboratively, and adaptability in a fast-paced environment.

As a valued member of our team, you can expect a competitive salary package, comprehensive benefits, including private health care services and access to employee assistance programs, opportunities for professional growth and development, and a collaborative work environment that prioritizes well-being and work-life balance.