Principal Regulatory Affairs Specialist jobs at Boston Scientific in Ireland, Galway

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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Advancing possibilities for a brighter tomorrow

Advises and guides the company and demonstrates leadership on EHS matters to ensure the safety and health of the workforce, and the protection of the environment. Ensures the company is aware of, and complies with applicable environmental, health and safety legislative and other requirements.

Key Responsibilities

• Support and improve the Health and Safety Management System. Participate in audits of the Management System on a scheduled basis.
• Stay informed of current and new Health and Safety regulatory requirements and other guidelines considered for implementation.
• Maintain plant statistics, performance to goals and other records necessary to maintain the EH&S Management System status and comply with regulatory requirements.
• Represent Boston Scientific to outside parties, such as regulatory agencies.
• Maintain metrics for assessing EH&S effectiveness.
• Works with Supervisors, Trainers and Technicians to identify and control significant environmental, health and safety impacts of operations.
• Ensures that all required records are prepared and maintained.
• Participates in and prepares for EHS inspections by external agencies, and all system audits.
• Investigates, prepares, communicates and manages reports on incidents, injuries, ill-health, and corrective actions as required.
• Conducts risk assessments including ergonomic evaluations.
• Maintains and updates SDS’s and chemical inventories.
• Supports and contributes to the site’s life safety programs to include emergency response.
• Understands and proactively follow through on the Health and Safety Management Procedures that have been identified as relevant to position.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personal, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Educational Requirements & Skills

• Level 8 qualification in Health & Safety.
• Requires in-depth conceptual, practical and technical and/or functional knowledge of principles and theories in own job function and general understanding of related job functions
• Has experience in applying this knowledge in a variety of situations to accomplish work
• Applies understanding of key business drivers in the context of the organization's industry and how closely related teams integrate with others to accomplish their objectives and drive efficiencies
• Supports team members by setting an example, coaching and providing feedback and guidance
• May lead safety projects or project steps with manageable risks and resource requirements
• Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy to propose alternatives to understanding their impact on the business or apply judgment based on experience to develop new solutions
• Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems
• Impacts quality and effectiveness of customer, operational, project/program or service activities within own team and other related teams
• Exerts some influence on the overall objectives and long-range goals of the organization
• Exchanges complex information with others, potentially guiding and persuading others
• Regularly participates in discussions and presentations in small, cross-functional meetings, logically presenting information to convey key messages.

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