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Reg Affairs Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Cork, IE

  • Location: Cork - Hybird
  • Req Number: 557380 
  • Contract type: Permanent 



At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.




Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


Purpose Statement:

Responsible for Regulatory Affairs support of the site, submissions and regulatory compliance.


Roles & Responsibilities:

  • Working as part of a team responsible for Regulatory Activities at Boston Scientific. 
  • Assist in preparation of Technical Documentation for all site products.
  • Be very familiar with the Regulatory Requirements of MDR 2017/745 to convert MDD Regulatory files to EU MDR 2017/745 requirements. .
  • Writing of US submissions such as Annual Reports, 30 Day notices etc.
  • Review and approve documentation related to product release/changes through the change notification process.
  • Provide input, review and approve facility regulatory activities such as labelling.
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
  • Support the QA function during external agency audits.
  • Support sustaining activities for legacy products by being part of core teams, giving advice on Regulatory strategies, and writing submissions for any potential impact on submission activity.
  • Support strategy and submission activities for new product development


Education & Experience:

  • Minimum qualification required: Bsc Science degree. 
  • Regulatory experience preferred but not essential
  • Minimum 3 years experience in a Health Care environment in a technical function. Pharmaceutical experience an advantage.
  • Experience in an MDD, FDA, ISO, GMP regulated environment
  • Strong team member with the ability to identify and drive regulatory compliance improvements
  • Good administrative/organizational ability with excellent attention to detail.
  • Technical writing ability.
  • Excellent communication skills
  • Excellent analytical/decision making skills


About us


Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth


At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.


As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Job Segment: Compliance, Medical Technology, Product Development, Recruiting, Regulatory Affairs, Legal, Healthcare, Human Resources, Research

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