Regulatory Affairs Director

About Eakin Healthcare Group

We are a leading healthcare organization dedicated to delivering innovative solutions for respiratory and wound care. Our team is passionate about making a difference in people's lives, and we're seeking a highly skilled Regulatory Affairs Manager to join our Respiratory therapeutic area in Coleraine.

Job Description:

This is a fantastic opportunity for a seasoned Regulatory Affairs professional to take on a key role in ensuring the success of our regulatory and quality strategy. As Regulatory Affairs Manager, you will be responsible for providing expert guidance and direction on regulatory matters within our Respiratory therapeutic area. You will work closely with cross-functional teams to establish systems for registration, develop regulatory strategies, and ensure compliance with domestic and international regulations.

Key Responsibilities:

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• Establish and maintain relationships with external stakeholders, including suppliers, test houses, notified bodies, and competent authorities
  
• Develop and implement regulatory strategies to support business goals, ensuring compliance with relevant laws and regulations
  
• Maintain up-to-date knowledge of regulatory requirements and communicate effectively with management and project teams
  
• Define and manage regulatory risk management activities within the organization
  
• Provide input and direction into new product development, ensuring regulatory compliance
  
• Represent the RA team on matters of regulatory compliance, providing guidance and ensuring adherence to company policies
  
• Prepare and submit high-quality technical files, design dossiers, and other necessary applications for regulatory approval
  
• Collaborate with the Quality Manager to represent the Respiratory therapeutic area at external agency and customer inspections
  
• Execute Field Safety Corrective Actions (FSCA) in a timely, thorough, and transparent manner, working closely with the Head of Group Operations Compliance and Head of Clinical & Regulatory Affairs
  
• 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 and support the internal audit schedule, conducting inspections when assigned
  
• Work with cross-functional teams, providing input when required, and contribute to budget preparations in conjunction with the Head of Clinical & Regulatory Affairs
  
• Ensure that all assigned budgets are monitored and delivered, providing regular reports to the Head of Clinical & Regulatory Affairs
  

Requirements:

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• Diploma, certificate, or formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and professional experience in regulatory affairs or quality management systems relating to medical devices
  
• Significant professional experience in regulatory affairs or quality management systems relating to medical devices, ISO Standards, and FDA CFR in a continuous improvement environment
  
• Strong communication skills, both verbal and written, with an ability to assess priorities based upon wider business demands
  
• Ability to work as part of a team, using Microsoft Office, Excel, Word, and PowerPoint effectively, and holding a 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
  

Competencies:

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• Manages complexity by making sense of complex information to solve problems effectively
  
• Decision quality by making good and timely decisions that keep the organization moving forward
  
• Balances stakeholders by anticipating and balancing the needs of multiple stakeholders
  
• Resourcefulness by securing and deploying resources effectively and efficiently
  
• Ensures accountability by holding self and others accountable to meet commitments
  
• Collaborates by building partnerships and working collaboratively with others to meet shared objectives
  
• Communicates effectively by developing and delivering multi-mode communications that convey a clear understanding of unique audience needs
  
• Being resilient by rebounding from setbacks and adversity when facing difficult situations
  

Working Relationships:

You will work closely with the Regulatory team in our Respiratory therapeutic area in Coleraine to ensure regulatory compliance, alongside QA/RA functions across Eakin Healthcare to encourage shared learnings, consistency, and opportunities for improvement. You will also interact with Group-wide manufacturing to support ongoing post-market compliance and collaborate with the Commercial team(s) to understand commercial implications of regulatory requirements.

Salary: £55,000 - £65,000 per annum, depending on experience