Regulatory Affairs Specialist

2 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €70,000 - €95,000

Job Title:

Regulatory Compliance Expert

As a Regulatory Compliance Expert, you will play a critical role in ensuring our medical devices meet the highest regulatory standards. This position requires a unique blend of technical expertise and business acumen.

About the Role:

This is an exciting opportunity to work with a dynamic team to develop and implement strategies that drive compliance and growth. You will be responsible for ensuring all products meet regulatory requirements, managing day-to-day regulatory activities, and providing strategic insights to cross-functional teams.

Main Responsibilities:

  • Develop and implement compliance strategies to ensure regulatory requirements are met
  • Manage day-to-day regulatory activities, including submissions and audits
  • Provide strategic insights to cross-functional teams on product development plans
  • Work closely with the QA Manager to ensure the effectiveness of the QMS
  • Evaluate manufacturing and labeling changes for regulatory impact
  • Maintain awareness of global regulatory legislation and assess its impact on business
  • Support the team with CE mark submissions, significant changes, and notified body interactions
  • Carry out other regulatory-related duties as required

Requirements:

  • Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company
  • Regulatory certifications in MDR desirable
  • A minimum of 4 years of experience in the medical device industry
  • Thorough understanding and knowledge of ISO 13485 and, ISO 14971, MDD & MDR
  • Proven track record with the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem-solving and communication skills
  • Must be self-motivated, highly organized, and detail-oriented

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