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:
At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work.  Global Regulatory Affairs Operations team is looking for a process driven individual who can be a contributing member of a global regulatory work environment. This position is part of the Global Regulatory Operations Group supporting all business units (Neuromodulation, Peripheral Interventions, Endoscopy, Urology and Pelvic Health, Cardiac Rhythm Management, Electrophysiology, Watchman, Interventional Cardiology Therapies, Cardiac Surgery and Structural Heart/Aortic). This position will report into the Regulatory Center of Excellence Manager responsible for improving the global product change assessment process. 
The individual will be supporting multiple business units across different time zones and requires the ability to work with and support various teams in a remote setting. The successful candidate will be instrumental in creating and executing new and improved regulatory operations strategies, and streamlining activities related to product change assessments and audit readiness in support of internal and external inspections. The individual will manage multiple projects, be responsible for leading workstreams, requiring delegation of work and review of others' work product. Additional duties include developing procedures, maintaining procedures, and developing department processes and systems for change assessments. Primarily interfaces with regulatory affairs teams, project leaders, and management. 

Your responsibilities will include:

• Lead product change assessment efforts globally on behalf of all regulatory teams including but not limited to:
• Creating regulatory strategy for the change assessment process
• Authoring and submitting MDD and EU MDR submissions for change assessments.
• Support and draft change assessment for FDA and Notified Body (NB) questions and correspondence
• Monitoring of change assessment regulatory changes and ensuring company readiness
• Providing consultation on change assessment interpretations and RA impact to all stakeholders
• Broaden role to include product change assessment expertise in all markets outside of USA/EU
• Regularly interaction with product SMEs, Global RA Ops team members, change assessment project members, and periodically with Divisional and/or Country Regulatory representatives
• Interpret and enforce regulatory documentation handling, formatting standards, policies, and standard operating procedure requirements. 
• Develop and implement regulatory operations processes and systems for product change assessments, department procedures and improve overall effectiveness of the Regulatory Affairs function. 
• This role includes identifying and implementing metrics to enhance business efficiencies for the product change assessment process.
• Monitor and analyze the impact of new or changing regulations, law enforcement actions and other changes that impact product regulation around the world. 
• Develop key partnerships across functional groups and business units to ensure best practices. Participate and guide decision-making process for IT system enhancements and new support software implementation within regulatory affairs. 
• Drive functional collaboration to identify topics or trends that require escalation to functional senior leadership. 
• Assist in the creation, deployment and maintenance of Regulatory procedures and training programs for product change assessment process.
• Train and mentor other regulatory employees on the change assessment process

Required qualifications:

• Minimum of a bachelor’s degree, preferably in a scientific or engineering discipline
• Minimum of 7 years of medical device, regulatory experience ideally with EU submissions
• Experience and knowledge in US & EU medical device product change assessments
• Fluent in English (oral and written) with strong oral and written communication skills

Preferred qualifications:

• Ability to effectively manage multiple projects
• Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases 
• Organizational skills, highly detail oriented, and effective project management skills.
• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. 
• Flexible with changing priorities, self-motivated, strong work ethic and attention to detail 
• Strong project management skills, ability to efficiently manage multiple projects and priorities and the ability to complete multiple simultaneous assignments per deadlines with minimal supervision. 
• Strong customer service skills to interact with individuals at various levels of the organization and external contacts when necessary.

Requisition ID: 558856

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 is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. 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.