Senior Regulatory Affairs Specialist

Boston Scientific; Cork; Hybrid; EUR 65,000 - 85,000; Full time

Job summary

A leading medical solutions company in Ireland is seeking a Senior Regulatory Affairs Specialist to develop regulatory strategies and submit filings for medical devices. The role is hybrid, requiring at least three days in the office, and candidates should have a Level 8 STEM degree and at least 5 years of experience in regulatory affairs. Strong communication and problem-solving skills are essential. The company offers diverse career development opportunities.

Benefits

Access to training and tools

Career progression support

Flexible working conditions

Qualifications

• A minimum of 5 years of regulatory affairs or related experience.
• Experience assessing product changes for regulatory compliance.
• Experience in authoring regulatory submissions for US and EU.

Responsibilities

• Develop regulatory strategies for medical devices.
• Coordinate and submit regulatory filings for products.
• Review product changes for compliance with regulations.

Skills

Regulatory filing coordination

Project management

Communication skills

Problem-solving skills

Technical documentation review

Education

Level 8 Honours Bachelor’s Degree in STEM

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Overview

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance. At Boston Scientific, you’ll work with diverse, high-performing teams to tackle important health industry challenges. We offer access to the latest tools, information and training to help you advance your skills and career, with support for progression aligned to your ambitions. We are seeking a Senior Regulatory Affairs Specialist on a permanent basis to join our team. This role can be based at any of the three Irish sites: Ireland-Cork, Ireland-Clonmel, or Ireland-Galway. It is a hybrid position (in office minimum three days per week) with 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.

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 Regulatory Affairs on cross-functional projects, including 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
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all documented quality processes

Qualifications

• Education & Experience: A minimum of a Level 8 Honours Bachelor’s Degree in STEM
• At least 5 years of regulatory affairs or related experience
• Experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• 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 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
• Ability to 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

About Boston Scientific and Equality of Opportunity

As a leader in medical science, we are committed to solving challenges that matter most, united by a deep caring for human life. Our mission to advance science for life aims to transform lives through innovative medical solutions that improve patient lives, create value for customers, and support our employees and communities.

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 a reasonable accommodation during the recruitment process, please email [e-mail].

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers