Senior Regulatory Affairs Specialist

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Senior Regulatory Affairs Specialist on a permanent basis to join our team.

Job Purpose:

The Senior Regulatory Affairs Specialist – eRIM Process Support supports the expansion of features in Boston Scientific’s electronic Regulatory Information Management (eRIM) system and the adaptation of processes to integrate the technology. This individual works under direction of the eRIM Process Lead (Req 624200) on the business support team and partners closely with the Product Owner, Data Lead, Change Management and Training Lead, and cross-functional Regulatory Affairs stakeholders to ensure global regulatory processes are clearly defined, fit for purpose and scalable across phases of the eRIM program. This role will report into Global Regulatory Affairs Operations, a corporate/global function.

As part of our continued team growth, we are expanding our team within this function. Please visit the Boston Scientific Careers site to explore related openings and apply to the position that best matches your background.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Key Responsibilities:

Process development and ownership

• Serve as a core team member for the eRIM program, contributing to the design and implementation of the global RIM solution and operating model.
• Support the transformation, development, and documentation of end-to-end regulatory business processes aligned with eRIM program phases, including worldwide authorizations and registrations, regulatory submission planning and tracking, submission and correspondence storage, international change notification and response and future-state regulatory processes beyond initial go-live.
• Define clear process flows, business rules and decision points that align with regulatory requirements and system capabilities.

System and requirements collaboration

• Partner with the Product Owner to translate regulatory process needs into clear system requirements, user stories and acceptance criteria.
• Collaborate with the Data Lead to define regulatory data elements and attributes, support data standards and governance decisions and ensure alignment between processes, data capture and downstream use.
• Act as a key business liaison to ensure regulatory processes are accurately reflected in system configuration.

Documentation and work instructions

• Author and maintain high-quality process documentation, including work instructions (WIs), standard operating procedures (SOPs), knowledge sharing documents (KSDs) and other supporting guidance and training-ready materials in collaboration with the Change Management and Training Lead.
• Ensure documentation is clear, concise and suitable for a global regulatory audience and external auditing bodies.

Stakeholder engagement and communication

• Engage global and regional Regulatory Affairs stakeholders to gather input, understand current-state practices and assess the impact of new processes.
• Evaluate diverse feedback, incorporate value-added input and clearly communicate decisions and rationale.
• Clearly articulate process expectations, roles and responsibilities across functions and regions.

Change enablement and adoption

• Support change management activities by providing strong process context and rationale for change.
• Partner with training and change leads to support effective rollout, adoption and continuous improvement of eRIM processes.
• Serve as champion for the strategic advantages of an enterprise-wide RIM system.

Education & Experience:

• Honours Bachelor’s degree (level 8) in life sciences, engineering, pharmacy, public health, communications or a related discipline.
• Minimum of 5 years' experience in Regulatory Affairs or related compliance experience within the medical device industry.
• Demonstrated working knowledge of FDA, EU or international regulatory frameworks impacting medical device authorization and maintenance.
• Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint.

Preferred qualifications:

• Strong written and verbal communication skills, including the ability to translate complex regulatory requirements into clear, actionable guidance, with demonstrated writing, editing, critical-thinking skills and attention to detail.
• Experience with electronic Regulatory Information Management (eRIM) systems, such as Rimsys, Veeva or Honeywell.
• Familiarity with Boston Scientific Regulatory Affairs processes and organizational context.
• Demonstrated ability to influence without authority and collaborate effectively within cross-functional teams.
• Experience supporting large-scale system or process transformation programs.
• Experience working in global regulatory environments with regional and country-specific requirements.
• Strong organizational skills with an audit-ready mindset and documentation discipline.
• Learning agility and a continuous improvement orientation.
• Pragmatic problem-solving skills with a coaching mindset.

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!

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

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