Regulatory Affairs Manager I
(permanent) – Cork or Galway, Ireland.
Job Purpose
The Interventional Oncology and Embolization (IO&E) division at Boston Scientific seeks a regulatory leader to oversee EU and US medical device compliance for a diverse portfolio of minimally invasive treatment solutions.
Key Responsibilities
Lead a team of five Regulatory Affairs Specialists, providing training, coaching and career development.
Develop and execute a Regulatory Affairs Operational Excellence strategy to support EU MDR maintenance for the IO&E product portfolio.
Deliver training and guidance on EU MDR and US regulatory activities to ensure audit readiness and ongoing compliance.
Train new and junior staff on regulatory assessments for supplier, manufacturing and design changes.
Support global regulatory strategies for new product development projects.
Review and approve regulatory submissions to agencies, including 510(k)s ?????·MDR Technical Documentation.
Represent the division at monthly Notified Body meetings and during audit engagements.
Maintain patient safety and quality through adherence to the Quality Policy and all related procedures.
Education & Experience
A Level 8 Honors Bachelor's Degree in STEM.
Minimum 5 years of EU and US medical device regulatory affairs experience.
Experience evaluating product and manufacturing changes for regulatory compliance.
Experience authoring or supporting 510(k) and MDR Technical Documentation submissions.
Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
Strong analytical, research and problem-solving skills.
Excellent verbal and written communication abilities hakim.
Team-player with strong interpersonal skills.
Proven ability to manage multiple concurrent projects.
Adaptable to fast-paced, cross-functional environments minimal.
Boston Scientific is an equal-opportunity and affirmative action employer.
We are committed to providing reasonable accommodations for applicants and employees with a disability.
If you require an accommodation during the recruitment process, please email
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