Director of Compliance
Eakin Healthcare Group
Comber, Newtownards BT23, UK
Published today
Business Compliance
Full time
Director of Compliance
At Eakin Healthcare we put our patient at the heart of everything we do.
Fifty years ago, it all started with one man's mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive® seal.
Fast forward to today, and we're still keeping it in the family. We've grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. We're making a difference in three therapeutic areas:
We're good at what we do - come and join us!
ABOUT THE ROLE
As we continue to expand, we are seeking an experienced and dynamic Director of Compliance to lead and oversee all aspects of compliance within Eakin Healthcare, including Quality Assurance, Regulatory Affairs, Sustainability and Legal.
As Director of Compliance, reporting into the CFO you will be responsible for overseeing Eakin Healthcare's compliance programs in alignment with industry regulations, quality standards, and legal requirements. This senior leadership role will be pivotal in ensuring that Eakin Healthcare's operations, products, and services meet the required standards of regulatory and legal compliance in an efficient way. Ensuring our organisation is positioned to deliver against our ambitious international growth targets and allow innovation to thrive in a compliant environment.
KEY ACTIVITIES
Leadership and Strategy
Essential
Internal
Business Insight
Applying knowledge of business and the marketplace to advance the organisation's goals.
Manages Complexity
Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
Decision Quality
Making good and timely decisions that keep the organisation moving forward.
Strategic Mindset
Seeing ahead to future possibilities and translating them into breakthrough strategies.
Drives Results
Consistently achieving results, even under tough circumstances.
Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.
Develops Talent
Developing people to meet both their career goals and the organisations goals.
Manages Ambiguity
Operating effectively, even when things are not certain, or the way forward is not clear.
At Eakin Healthcare we put our patient at the heart of everything we do.
Fifty years ago, it all started with one man's mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive® seal.
Fast forward to today, and we're still keeping it in the family. We've grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. We're making a difference in three therapeutic areas:
- Ostomy
- Respiratory
- Surgical
We're good at what we do - come and join us!
ABOUT THE ROLE
As we continue to expand, we are seeking an experienced and dynamic Director of Compliance to lead and oversee all aspects of compliance within Eakin Healthcare, including Quality Assurance, Regulatory Affairs, Sustainability and Legal.
As Director of Compliance, reporting into the CFO you will be responsible for overseeing Eakin Healthcare's compliance programs in alignment with industry regulations, quality standards, and legal requirements. This senior leadership role will be pivotal in ensuring that Eakin Healthcare's operations, products, and services meet the required standards of regulatory and legal compliance in an efficient way. Ensuring our organisation is positioned to deliver against our ambitious international growth targets and allow innovation to thrive in a compliant environment.
KEY ACTIVITIES
Leadership and Strategy
- Oversee the Compliance function, including Quality Assurance, Regulatory Affairs, Sustainability and Legal, ensuring effective integration across these disciplines.
- Bringing strategic direction ensuring compliance becomes a competitive advantage for our organisation across innovation, production, and international expansion.
- Develop and execute the compliance strategy and targets, ensuring alignment with corporate objectives and regulatory requirements.
- Act as a trusted advisor to senior management on all related compliance matters. Remaining future focused on relevant industry developments, ensuring our business adapts to new requirements promptly and efficiently.
- Lead cross functional teams to drive compliance initiatives.
- Influence senior management and the board on positioning compliance developments as a significant opportunity for the organisation and as a critical aid to assist in patient innovation.
- Maintain In-depth knowledge of relevant regulations such as the UK Medical Device Regulations, EU MDR, FDA regulations, ISO standards, legal and sustainability standards.
- Present complex regulatory, quality, environmental and legal matters to non-expert stakeholders including senior management and the board.
- Oversee the development and implementation of all compliance management systems to ensure that all products meet applicable safety, quality, and performance standards.
- Lead internal and external audits and inspections, and ensure corrective actions are implemented effectively.
- Oversee the regulatory strategy for product registrations, ensuring that all products are compliant with UK and EU regulations, as well as international standards.
- Lead the function for submission process for new and existing products, including technical documentation, clinical evaluations and market entry ensuring timely approvals.
- Manage relationships with regulatory authorities, maintaining effective communication and ensuring prompt resolution of any issues.
- Oversee the development and implementation of the Eakin Healthcare sustainability strategic plan.
- Oversee the development of a portfolio of cross-functional sustainability programmes to achieve the company's long-term sustainability ambitions.
- Develop and maintain the reporting framework for sustainability governance across the organisation.
- Collaborate with other departments to promote sustainable practices and reduce the organisation's environmental footprint.
- Integrate sustainability principles into compliance strategies, to align with environmental, social, and governance (ESG) goals.
- Oversee the legal compliance function, ensuring adherence to all legal and contractual obligations related to the company's products, operations, services and corporate governance.
- Oversee the management of legal risks, including intellectual property, liability, and data protection (GDPR).
- Work closely with external legal counsel on complex matters and ensure legal documentation is aligned with regulatory and compliance requirements.
- Establish and maintain a company-wide compliance training program to ensure that all staff understand their responsibilities regarding quality, regulatory, sustainability and legal compliance.
- Foster a culture of compliance and continuous improvement across the organisation.
- Implement and maintain monitoring systems to ensure compliance with all applicable regulations and standards.
- Report regularly to the executive leadership and Board of Directors on compliance status, emerging risks, and mitigation efforts.
- Maintain up-to-date records of compliance activities, audits, and inspections.
- To embrace, foster and drive Eakin Healthcare's vision, values, and ways of working.
- To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy
- To adhere to the company's Quality policy and Environmental policy
- To undertake other duties as may be reasonably required.
Essential
- Significant experience in Quality Assurance and Regulatory Affairs
- Significant expertise in global regulatory frameworks (MDR, MDSAP, FDA, ISO 13485) for compliant market access preferably in the medical device manufacturing industry
- Proven track record of driving significant revenue growth and operational optimisation.
- Experienced in managing Notified Body functions and delivering client-focused solutions.
- Successfully obtained MDR, FDA approvals, CE markings, and other regulatory clearances for various products
- Effective at building and retaining high-performance teams, scaling capacity, and fostering resilience.
- Strategically expanded market reach through innovative solutions and global product approvals
- Demonstrated success in leading multi-site quality and regulatory teams, driving continuous improvement initiatives to enhance efficiency, profitability, and compliance.
- Ability to influence senior management and the board on compliance issues and to navigate complex compliance challenges.
- Demonstrable experience of leading compliance to sustainability legislation and regulations.
- Strong written and verbal communication skills, with the ability to present complex regulatory, quality, and legal matters to non-expert stakeholders.
- Degree in Life Sciences, Engineering, Law, or related field
- Experience of ESG monitoring and reporting and overseeing the portfolio of sustainability projects.
- Comprehensive understanding of legal requirements with proven track record of management of legal risks
- Knowledge of leveraging AI and machine learning to streamline regulatory processes and accelerate market entry.
- An understanding of legal issues related to medical devices, including intellectual property, product liability, and contract law.
Internal
- Commercial
- Operations
- R&D
- Finance, HR
- Regulatory Bodies
- Auditors
- International distribution partnerships
- Clinician and patient groups
- 4 Direct Reports
- Regular travel across core sites
Business Insight
Applying knowledge of business and the marketplace to advance the organisation's goals.
Manages Complexity
Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
Decision Quality
Making good and timely decisions that keep the organisation moving forward.
Strategic Mindset
Seeing ahead to future possibilities and translating them into breakthrough strategies.
Drives Results
Consistently achieving results, even under tough circumstances.
Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.
Develops Talent
Developing people to meet both their career goals and the organisations goals.
Manages Ambiguity
Operating effectively, even when things are not certain, or the way forward is not clear.