Principal Regulatory Affairs Specialist

Overview

Boston Scientific is seeking a Principal Regulatory Affairs Specialist on a permanent basis to join our team. This role can be based out of either of the following Irish sites: Ireland-Galway; Ireland-Cork.

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

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com

Job Segment: Regulatory Affairs, Compliance, Medical Device, Manufacturing Engineer, Law, Legal, Healthcare, Engineering

#J-18808-Ljbffr

---