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’ve been recognised as a Great Place to Work®! And we’re proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women.

At Eakin Healthcare, we’re united by one mission: working together to improve lives – just like we’ve been doing for over five decades.

WHY JOIN US?

We’re good at what we do – come and join us and you can benefit from:

• Blended Working
• Bonus
• 25 days holiday plus bank holidays (rising to 28)
• Option to buy holiday days
• Wellbeing Programme
• Health Cash Plan
• Pension
• Life Assurance
• Enhanced Maternity/Paternity
• Cycle to Work Scheme
• Referral Scheme
• Long Service Awards
• Free Parking

ABOUT THE ROLE

Reporting to the Regulatory Affairs Manager, the Compliance Administrator based from the Coleraine site is responsible for supporting the group in ensuring requirements for medical device regulatory compliance are identified, achieved and maintained. This is a 1 year fixed term contract covering maternity leave.

KEY RESPONSIBILITES

• Providing a wide range of administrative and support services to help the Regulatory team carry out their work more efficiently and effectively.
• Collating information and producing documents to support the operation and management of the department.
• Managing filing and administrative systems to ensure that information is recorded, secure and accessible.
• Providing support and guidance to allocated staff in the team to facilitate their development and achievement of objectives.
• Completion of all administrative activities on time, and in full.
• Serve as point of contact and issue timely response to queries, emails or issues.
• Accurate data entry ensuring all systems are kept up to date, and essential documents are managed accordingly.
• Use of Microsoft Excel, to produce regular reports.

Critical Success Factors

• Providing administration support during external and unannounced audits.
• Responding to requests for from internal departments to support business functionality.
• Demonstrate improvement in efficiency and responsiveness of regulatory affairs function.
• Support the Regulatory team in achieving and maintaining compliance with 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 skills
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite
• Attention to detail
• Educated to GCSE level or equivalent

Desirable

• 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.

Nimble learning

Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder.

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.