Regulatory Quality Compliance Manager

If you have a regulatory compliance and/or medical devices quality compliance background and are seeking a role with genuine career potential, this position might be just right for you.
  
We are partnering with a thriving South Manchester business in the medical supplies sector to support its ambitious growth plans in the coming years. It is a stable company with over thirty years of expertise and a strong reputation among its clients.
  
The company provides high-quality, non-pharmaceutical medical consumables to a diverse range of clients, including healthcare providers, research institutions, and veterinary practices across the UK and Europe.
  
Due to ongoing growth, they are looking for an experienced Regulatory Compliance Manager to oversee their expanding portfolio of over 4,000 SKUs and ensure that they remain focused on quality and compliance with existing and new regulations related to the medical devices sector.
  
While their growth has been impressive in the past few years, it has meant that the strong infrastructure could still be enhanced. With this in mind, your experience in this field is essential, as you would be the ‘go-to’ person within the business.
  
The company fosters a diverse and inclusive culture, prioritising employee growth and career development as essential to success. The role will be varied and fundamentally involves you taking responsibility for establishing, maintaining, managing, and monitoring standards, processes, communications, training, and systems to ensure compliance with legal, customer, and accreditation requirements.
  
This is one of those roles that doesn’t come along often and offers the chance to make a meaningful impact on both the business growth plans and your own career aspirations.
  
Reporting to senior management, you would be instrumental in overseeing compliance and quality across both the UK and EU regions. Working independently, you will collaborate cross-functionally to champion the importance of compliance and quality throughout the organisation.
  
Main duties include:  

Ensuring the business maintains compliance with all relevant legislation
Actively monitoring new regulations and legislative changes that may affect the business
Maintaining and updating all compliance documentation and producing monthly reporting data
Upholding ISO 9001 and 14001 standards
Ensuring Health & Safety regulations are adhered to
Collaborating with various departments to effectively promote a positive quality and safety culture throughout the business
Being visible and approachable from shop floor to boardroom, ensuring consistent standards are upheld
Liaising with external consultants as necessary   We are looking for:  

Proven experience within a product compliance/and or regulatory and quality role (medical supplies/medical devices/pharma)
Robust experience working to ISO 9001, 14001 and ideally 13485 standards
Previous experience as a Person Responsible for Regulatory Compliance (PRRC) would be desirable (though not essential)
Ability to persuade, influence, and collaborate effectively with colleagues across all departments
A self-motivated individual with the ability to work autonomously, take initiative and assume ownership within the compliance function
Adaptability and resilience to thrive in a dynamic and rapidly growing business environment
Ability to undertake some short European trips periodically   In return you can expect:  

A competitive salary of circa £50k
25 days annual leave plus Bank Holidays
The opportunity to join a forward-thinking company during an exciting period of expansion
A newly created role where you can make a significant impact and shape the compliance strategy
A supportive and inclusive work environment that values its employees and encourages career development
Company-provided laptop
DIS benefit
24/7 private GP access
Comprehensive mental health support for you and your family
Access to a financial wellbeing service
Regular social events, including a summer BBQ and Christmas party
Comprehensive training and ongoing support
Opportunities for overseas travel a few times per year
Flexible start times (within a core hours framework)   If you are interested in this position, please contact Rachel on: (phone number removed) or email a copy of your CV using the link