Boston Scientific Principal Regulatory Affairs Specialist 

Ireland, Galway 

573275246

This role can be based out of either of the following Irish sites:

Job Purpose:

Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.

Key Responsibilities:

• Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
• Assist with departmental policy and procedure implementation.
• Assist with Regulatory Affairs training to cross functional groups.
• Generate and implement regulatory strategies for new and modified medical devices.
• Act as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Act as a team member in product development programs and demonstrate a good understanding of the product development process.
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
• Review and update of EU Regulatory Documentation including Technical Documentation and Post Market Surveillance deliverables such as SSCPs.
• Prepare FDA regulatory files such as pre-market approval (PMA’s), supplements and amendments, 30-day notices, annual reports and 510ks.
• Review device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.
• Interface with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
• Review and sign-off on product and manufacturing changes for compliance with applicable regulations
• Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
• Maintain and enhance cross-functional team relationships.
• Review applicable Corporate SOPs for effect on local regulatory processes and systems.
• Provide input, review and approve artwork for labeling and instructions for use.
• Participate in Regulatory body audits, such as FDA, competent authorities and Notified Bodies.
• Liaise and provide support to regulatory colleagues in the international markets.
• Demonstrate and actively promote highest level of professional regulatory discipline.
• Liaise with both middle and senior management on any regulatory issues relating to their area.

Education & Experience

• Level 8 Bachelors Degree in STEM (regulatory affairs or relevant discipline)
• Minimum of 7 years experience in Regulatory Affairs or a related discipline (e.g. Quality, R&D, Post Market) within the medical device industry
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
• Prior experience with a variety of regulatory submissions for US and EU MDR
• Adaptable and able to work independently with minimal supervision in a fast-changing environment
• Demonstrated leadership, strategic thinking, project planning, and project management skills
• Excellent oral/written communicator with ability to articulate ideas, transfer knowledge efficiently and effectively, influence and engage colleagues
• Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization
• Ability to effectively lead multiple regulatory projects and priorities
• Experience working directly with FDA, Notified Bodies, or other regulatory agencies
• Experience with data analytics or AI tools to identify and drive operational efficiencies is a plus

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