Regulatory Affairs Manager - Mat Leave / FTC

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 proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium and Luxemburg.

We’re good at what we do – come and join us!

ABOUT THE ROLE

Reporting to the Head of Clinical & Regulatory Affairs, the Regulatory Affairs Manager will be responsible for providing Regulatory direction and guidance within our Respiratory therapeutic area in Coleraine.

The Regulatory Affairs Manager role is key to the success of the regulatory and quality strategy, ensuring the development of regulatory strategies supporting New Product Development (NPD) and Notified Body communications / submissions.

The Regulatory Affairs Manager will act as the Person Responsible for Regulatory Compliance (PRRC) for the business highlighted above.

KEY ACTIVITIES

• In conjunction with multi departmental teams, establish systems for registration to approve, develop, refine, and execute regulatory strategies to support both individual and collective business goals.
• Maintain up-to-date knowledge on both domestic and International Regulatory requirements, effectively communicating to management and where required, project teams.
• Responsible for defining and managing regulatory risk management activities within the organisation.
• Provide input and direction into new product development.
• Represent the RA team on matters of regulatory compliance, providing guidance and ensuring compliance.
• Provide technical documentation supporting regulatory registration in assigned countries of strategic plan.
• Develop, prepare, and have ready for submission, high quality technical files, design dossiers and other necessary applications for regulatory approval.
• With the Quality Manager, represent the Respiratory therapeutic area at all external agency & customer inspections.
• In conjunction with the Head of Group Operations Compliance and Head of Clinical & Regulatory Affairs execute Field Safety Corrective Actions (FSCA) in a timely, thorough, and transparent manner.
• Act in line with the responsibilities for Person Responsible for Regulatory Compliance (PRRC) encompassing Technical documentation, PMS, Vigilance reporting and Declaration of Conformity commitments for the UK Businesses.
• Review and approve labelling, product and process changes, product documentation as it pertains to regulatory filings and clinical evidence.
• Deliver Internal regulatory training for departments.
• Support the Internal audit schedule, conducting Inspections when assigned.
• Work with cross functional teams providing input when required.
• Contribute to budget preparations in conjunction with the Head of Clinical & Regulatory Affairs.
• Ensure that all assigned budgets are monitored and delivered.
• Provide reports on agreed frequency on all matters associated with regulatory compliance to the Head of Clinical & Regulatory Affairs.

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.

KEY SKILLS 

Essential

• A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Significant professional experience in regulatory affairs or in quality management systems relating to medical devices, ISO Standards and FDA CFR in a continuous improvement environment.
• Strong communication skills, both verbal and written.
• An highly organised individual who can assess priorities based upon the wider business demands.
• Ability to work as part of a team.
• Capability to use Microsoft Office, Excel, Word, and PowerPoint.
• Full UK Driving Licence.

Desirable

• Educated to degree level.
• Experience in the ostomy or wound care industry.
• Understanding of ISO 13485, 14971, 15223, UKMDR 2002, MDD 93/42/EEC AND MDR 2017/45.
• Methodical, with analytical and problem-solving skills and an understanding of measurement principles and techniques.

The successful candidate

• Will be able to work in a multi-functional, multi-disciplinary team and to build relationships with peers.
• Will be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
• Will have excellent time management skills and effectively plan, resource, and execute multiple projects simultaneously
• Will be willing to travel to Eakin Healthcare group facilities including Comber and Cardiff with opportunities for additional travel, as required by your role.
• Will be prepared to take a hands-on approach to all aspects of regulatory compliance and to take on ‘ad-hoc’ projects as the business requires.

KEY WORKING RELATIONSHIPS

Internal:

• Working within the Regulatory team in our Respiratory therapeutic area in Coleraine to ensure regulatory compliance
• Working alongside QA/RA functions across Eakin Healthcare to encourage shared learnings, consistency, and opportunities for improvement
• Group wide manufacturing to support on-going post market compliance
• Working alongside the Commercial team(s) to understand the commercial implications of regulatory requirements

External

• Suppliers
• Test houses
• Notified bodies
• Competent authorities

Additional Information

• Occasional travel may be required to other Eakin sites

COMPETENCIES

Manages Complexity
Making sense of complex, high quality and sometimes contradictory information to effectively solve problems.

Decision Quality
Making good and timely decisions that keep the organization moving forward.

Balances Stakeholders
Anticipating and balancing the needs of multiple stakeholders.

Resourcefulness
Securing and deploying resources effectively and efficiently.

Ensures Accountability
Holding self and others accountable to meet commitments.

Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.

Communicates Effectively
Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Being Resilient
Rebounding from setbacks and adversity when facing difficult situations.

#HP