Regulatory Compliance Specialist

1 week ago


Coleraine, United Kingdom Eakin Healthcare Group Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team in Coleraine, responsible for providing regulatory direction and guidance within our Respiratory therapeutic area.

Key Responsibilities
  • Establish and implement regulatory strategies to support New Product Development (NPD) and Notified Body communications/submissions.
  • Maintain up-to-date knowledge on domestic and international regulatory requirements and communicate effectively with management and project teams.
  • Define and manage regulatory risk management activities within the organisation.
  • Provide input and direction into new product development and represent the RA team on matters of regulatory compliance.
  • Develop, prepare, and submit high-quality technical files, design dossiers, and other necessary applications for regulatory approval.
  • Represent the Respiratory therapeutic area at external agency & customer inspections and execute Field Safety Corrective Actions (FSCA) in a timely manner.
  • Review and approve labelling, product, and process changes, product documentation as it pertains to regulatory filings and clinical evidence.
Requirements
  • Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline and significant professional experience in regulatory affairs or quality management systems.
  • Strong communication skills, organisational ability, and capability to use Microsoft Office, Excel, Word, and PowerPoint.
  • Fully qualified Person Responsible for Regulatory Compliance (PRRC) with an understanding of ISO 13485, 14971, 15223, UKMDR 2002, MDD 93/42/EEC, and MDR 2017/45.
  • Methodical thinker with analytical and problem-solving skills, excellent time management, and ability to work in a multi-functional team.
Competencies
  • Manages Complexity: Making sense of complex information to solve problems.
  • Decision Quality: Making good decisions that keep the organization moving forward.
  • Balances Stakeholders: Anticipating and balancing the needs of multiple stakeholders.
  • Resourcefulness: Securing and deploying resources effectively.
  • Ensures Accountability: Holding self and others accountable to meet commitments.
  • Collaborates: Building partnerships and working collaboratively with others.
  • Communicates Effectively: Developing and delivering communications that convey a clear understanding of different audiences' needs.
  • Being Resilient: Rebounding from setbacks and adversity when facing difficult situations.
About Eakin Healthcare Group

We are a leading healthcare group with a strong presence in the respiratory therapeutic area. Our team is dedicated to providing innovative solutions and exceptional service to our customers.

Benefits
  • Estimated salary: £60,000 - £80,000 per annum, depending on experience.
  • Ongoing professional development opportunities.
  • A dynamic and supportive work environment.
  • The opportunity to work with a leading healthcare group and contribute to the success of our Respiratory therapeutic area.

Please note that this is a general job description and may be subject to change based on business needs. We are an equal opportunities employer and welcome applications from all qualified candidates.



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