Principal Regulatory Affairs Specialist - Interventional Cardiology

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, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.

Responsible for regulatory submissions supporting NPD, clinical trials and sustaining projects and on-going regulatory compliance activities for post market reporting/agency interaction.
 
Your responsibilities will include:

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
• Specific experience in strategic planning, preparation, and submission of PMA, IDE, Technical Files, and Design Dossiers is required. Experience in software and hardware submission is preferred.  Experience in Class II U.S. is a plus.
• Experience working directly with FDA is required.
• Acts as company representative, 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.
• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment.
• Team player with excellent interpersonal skills.
• Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Develops and implements departmental and divisional policies and procedures.
• Supports highly technical or major business segment product lines, special projects or strategic initiatives.

Required qualifications:

• A minimum of a bachelor’s degree in a scientific, technical, or related discipline
• A minimum of 7 years experience Regulatory Affairs in the medical industry
• Ability to travel at least 10%

Preferred qualifications:

• Professional certification(s), such as RAC, is preferred
• Excellent research and analytical skills
• Ability to manage multiple projects
• Demonstrated success in management of regulatory submissions activities
• Thorough understanding of global regulations
• Strong technical knowledge of medical products
• Strong technical understanding of relevant procedures, practices, and associated medical terminology
• Thorough understanding of clinical trial strategy and study design, and sponsor reporting requirements
• Thorough knowledge of product development process and design control
• Excellent written and oral communication, technical writing and editing skills
• Strong leadership, interpersonal and influencing skills
• Proficiency with Microsoft Office

Requisition ID: 560058

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.

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