Regulatory Affairs Specialist

3 days ago

Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €70,000 - €90,000
Job Title: Regulatory Affairs SpecialistJob Description

The position of Senior Regulatory Affairs Specialist entails overseeing activities related to maintaining and obtaining regulatory approval for medical devices. This includes evaluating the implications of device changes, developing comprehensive regulatory strategies for US, EU, and international markets, and coordinating submissions.

Key Responsibilities:
  • Develop strategic plans for device approvals across various regions.
  • Coordinate and submit regulatory filings for new and modified products.
  • Support cross-functional projects and review clinical study protocols.
  • Demonstrate unwavering commitment to patient safety and product quality.
Required Skills and Qualifications:
  • Mastery of a Level 8 Honours Bachelor's Degree in STEM fields.
  • Minimum of 5 years of experience in regulatory affairs or a related field.
  • Exceptional technical, research, and problem-solving skills.
  • Able to effectively communicate complex ideas verbally and in writing.
Preferred Skills:
  • Pharmaceutical and/or drug/device combination device expertise.
  • Clinical knowledge and experience.
  • Proficiency in Microsoft Office and Adobe Acrobat.

We are committed to advancing science for life through innovative medical solutions that enhance patient lives and create value for customers and employees.

We recognize the importance of diversity and inclusion in driving innovation. Our company is an equal opportunity employer, dedicated to providing reasonable accommodations for applicants and employees with disabilities.

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