Boston Scientific Senior Regulatory Affairs Specialist 

Ireland, Cork 

413149411

Job Purpose:

The Senior Regulatory Affairs (RA) Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Senior RA Specialist is responsible for assessment of device changes for regulatory implications.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Cork, Galway or Clonmel. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Key Responsibilities:

• Develop US, EU and international regulatory strategies for approval of medical devices
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments
• Develop and maintain positive relationships with regulatory body reviewers
• Review Technical and Labelling documentation for inclusion in regulatory filings
• Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required:

• A minimum of a Level 8 Honours Bachelor's Degree in STEM
• A minimum of 5 years of regulatory affairs or related experience
• Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred:

• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments
• Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage

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