Compliance Administrator in Coleraine

At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We have been recognised as a Great Place to Work! And we are proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we are united by one mission: working together to improve lives - just like we have been doing for over five decades. We are good at what we do come and join us!

ABOUT THE ROLE

Reporting to the Senior Regulatory Affairs Specialist, the Compliance Administrator based at the Coleraine site, supports the group in identifying, achieving, and maintaining medical device regulatory compliance requirements. This role is a maternity cover for approx 6 - 9 months. Part-time hours may be considered.

KEY ACTIVITIES

• Provide a comprehensive range of administrative and operational support services to enable the Regulatory team to work efficiently and effectively.
• Collate information and prepare documentation to support the effective operation and management of the Regulatory department.
• Manage filing, document control, and administrative systems to ensure information is accurate, secure, compliant, and readily accessible.
• Provide day-to-day support and guidance to allocated team members to support their development and achievement of objectives.
• Ensure all administrative activities are completed accurately, on time, and in full.
• Act as a primary point of contact for queries, emails, and issues, ensuring timely and professional responses.
• Perform accurate data entry, ensuring all systems are maintained, up to date, and essential documentation is appropriately managed.
• Use Microsoft Excel and other Microsoft Office tools to produce regular reports and maintain tracking logs.

Critical Success Factors

• Provide effective administrative support during internal, external and unannounced regulatory audits.
• Respond promptly and accurately to requests from internal departments to support overall business operations.
• Demonstrate improvement in the efficiency, responsiveness, and effectiveness of the Regulatory Affairs function.
• Support the Regulatory team in achieving and maintaining compliance with applicable regulations and standards, including EU MDD, UK MDR, EU MDR, ISO 13485, MDSAP and other national regulatory authorities in countries where our products are used.

Other

• 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.

WHAT WE'RE LOOKING FOR

• Essential

• Strong organisational and multitasking.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Attention to detail.
• Educated to GCSE level or equivalent.

• Experience in office administration.

KEY WORKING RELATIONSHIPS

• Internal Operations QARA Teams
• R&D Commercial Teams
• External Customers, Distributor, Importers and Authorised Representatives.
• Suppliers

ADDITIONAL INFORMATION

• Ability/willingness to develop within the role.
• Ability/willingness to attend training courses in relation to the role and the needs of the department.

COMPETENCIES

• Collaborates: Building partnerships and working collaboratively with others to meet shared objectives.
• Plans and aligns: Planning and prioritizing work to meet commitments aligned with organizational goals.
• Interpersonal savvy: Relating openly and comfortably with diverse groups of people.
• Being resilient: Rebounding from setbacks and adversity when facing difficult situations.
• Optimizes work processes: Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Builds networks: Effectively building formal and informal relationship networks inside and outside the organization.
• Instills trust: Gaining the confidence and trust of others through honesty, integrity and authenticity.
• Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.

Skills: Administrative Assistance, Data Entry, General Administration, File documents, Document Management