Regulatory Affairs Specialist

About the Role

The Regulatory Affairs Manager will be responsible for providing regulatory direction and guidance within our Respiratory therapeutic area in Coleraine. This 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.

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 organisation 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.