Principal Regulatory Affairs Specialist

Additional Location(s): N/A

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.

About the role:

The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces. Additionally, the Associate is responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support.

Your responsibilities will include:

• Perform as the Regulatory Affairs Lead team member on initiatives to transform how we address the unique needs of capital equipment life cycle within the quality system (from part creation, labeling and testing to distribution and servicing)
• Collaborate with cross functional partners (specifically Supplier Quality, Material Controls and Design Controls) as the Voice of Regulatory to deliver innovative solutions for achieving and maintaining compliance in the areas of Medical Electrical Equipment, Material Controls, Supplier Quality, and others
• Proactively influence global site and divisional partners and leadership in interpretation/understanding of new concepts and requirements and adoption of Best Practices. In addition, working to ensure understanding and translation of strategies, goals and the full scope of Business Transformation initiatives
• Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for process efficiencies
• Identify, establish business cases for, initiate and lead projects to address needs within the medical equipment space
• Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams
• Actively participate in advocacy streams to get a pulse on regulation trends and expectation as well as benchmark against other industry leaders (current areas for connection include repair, cybersecurity, and others)
• Author, revise and edit standard operating procedures and work instructions
• Participate as the Regulatory Affairs SME in assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed
• Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions
• Participate in training and mentoring of staff
• Participate in department systems development initiatives

Required qualifications:

• Minimum of a bachelor's degree
• Minimum of 5 years' experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
• Working knowledge of FDA, EU and/or international medical device regulations
• Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
• Ability to read and interpret global regulations and standards
• General understanding of product development process, design controls and quality system regulations
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)

Preferred qualifications:

• Degree or work experience in a scientific or technical discipline
• Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization
• Excellent written and oral communication, technical writing and editing skills
• Excellent research and analytical skills
• Ability to manage multiple projects simultaneously
• High sense of urgency and commitment to execution
• Proven leadership, collaboration and influencing skills
• Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions)

#LI-Hybrid

Requisition ID:588395

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 (NYSE: BSX) 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 recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.