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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 work.  In the Endoscopy division, we develop advanced technologies for diagnosing and treating diseases of the digestive system, airway and lungs.  Our products are available to be used throughout the world as a result of the regulatory team obtaining the global approvals.  It is a fast-paced, team-orientated, innovative environment that focuses on the patient first.    
 

Your responsibilities will include:

In this role, you will be responsible for product lines, technology, managerial, leadership, and employee development activities.

• Directs and coordinates activities of Regulatory Affairs employees.
• Assists in establishing project priorities, allocating resources and workload.
• Provides technical guidance to team during submission preparation and interaction with regulatory bodies.
• Reviews and edits submissions prepared by team members.
• Represents Regulatory Affairs at management updates.
• Provides short-range strategy formulation.
• Implements regulatory strategies for new and modified products.
• Assists with developing and implementing departmental policy and procedure.
• Provides Regulatory Affairs training/mentoring to employees.
• Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Oversees preparation and submission of global regulatory applications as appropriate as well as internal regulatory file documentation.
• Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off product and manufacturing changes for compliance with applicable regulations.
• Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure employees are trained to do their work and their training is documented.
   

What we’re looking for in you:

Required Qualifications

• Minimum of a Bachelor’s degree is required 
• Minimum of 7 years’ experience in Regulatory Affairs in the Medical Device industry
• Demonstrated success managing, leading, and/or developing others
• Demonstrated success managing regulatory submissions activities, including FDA and Notified Bodies
• Demonstrated success as the RA lead on cross-functional development teams
• Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations
• Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound product strategies
• Strong technical knowledge of medical products
• Excellent research and analytical skills
• Ability to manage multiple projects simultaneously
• Excellent written and oral communication, technical writing and editing skills
• Strong leadership, interpersonal and influencing skills
• Ability to work independently

Preferred Qualifications

• Degree in a scientific, technical, or project management discipline preferred
• Professional certification, such as RAC, preferred

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.