Regulatory Affairs Specialist

15 hours ago

Cork, Cork, Ireland beBeeRegulatory Full time €60,000 - €80,000

Job Description:

In this pivotal role, you will be responsible for navigating global regulatory submissions, ensuring timely annual reporting to notified bodies and competent authorities, and maintaining stringent compliance with industry standards and regulations. A working knowledge of medical device regulatory requirements and standard practices in the medical device industry is essential.

Key Responsibilities:
  • Support day-to-day regulatory activities, handling multiple projects related to regulatory compliance enhancements.
  • Assist in implementing MDSAP within the organization.
  • Collaborate with the team to obtain/retain country-specific regulatory registrations globally.
  • Work closely with interdisciplinary team members to ensure the effectiveness of the QMS in meeting regulatory demands.
  • Contribute to internal and external audits, including notified body audits as required.
Required Skills and Qualifications:
  • Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
  • Regulatory certifications in EU MDR and US FDA are highly desirable.
  • Thorough understanding of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards is essential.
  • Proven track record of successfully managing projects to deadlines.
Benefits:
  • Opportunity to work on complex regulatory projects.
  • Chance to collaborate with experienced professionals in the field.
  • Professional growth and development opportunities.
Others:
  • Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
  • Keep abreast of changes in domestic and international regulations and guidelines.

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