Senior Specialist, Interventional Cardiology, Regulatory Affairs Job

  • Anywhere

Company :
Boston Scientific

Location :
Osseo, Minnesota

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

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Description :
Date: Mar 24, 2021 Location: Maple Grove, MN, US, 55311 Company: Boston Scientific Additional Locations: Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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. Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space? At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. This is a place where you can find a career with meaningful purpose – where we value diversity, ensure everyone’s voice is heard and respected, and prioritize initiatives that promote awareness and celebrate personal, cultural, and demographic differences of our customers, patients, and workforce. About this role: We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs position supporting the only FDA cleared cerebral embolic protection system, an exciting source of growth for Boston Scientific. This candidate will help drive direction from the core team level and provide strategic inputs to RA senior leadership. We are looking for a future regulatory leader with a problem-solving mentality and a strong desire to identify, comprehend, and assimilate knowledge across regulatory, engineering, and clinical disciplines. This position will be a key contributor in the global regulatory facilitation of design enhancements, next-gen devices, MDR compliance, and clinical strategy within BSC’s Structural Heart Franchise. This website summarizes some of Boston Scientific’s other exciting investments in the rapidly growing Structural Heart space. Your responsibilities will include: * Develops and implements regulatory strategies for new and modified products. * Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions. * Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. * Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations. * Identifies, understands and communicates new or evolving regulatory requirements pertinent to Interventional Cardiology, TAVR, and Structural Heart technologies. * Works cooperatively with R & D, process development, quality, manufacturing, biocompatibility, clinical, and marketing on complex projects to ensure success. * 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. * Tracks key competitive technologies and provides regulatory assessment in collaboration with new business development and marketing in order to gain alignment with franchise stakeholders. * Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. What we’re looking for in you: Minimum Qualifications * Bachelor’s degree in a scientific or technical discipline, preferably a BS or MS in Engineering or Biological Sciences * 5+ years Medical Device Regulatory Affairs experience, or 3+ years Medical Device Regulatory Affairs experience and 3+ years of experience in a related discipline (e.g., R & D, Quality, Clinical, Medical Affairs, Biocompatibility) within the medical device industry * Thorough understanding of US and EU medical device regulations * Thorough understanding of product development process and design controls * Strong technical knowledge of medical devices, procedures, practices, and related terminology * Excellent organizational, communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources Preferred Qualifications * Submission experience including 510(k), IDE, Technical Files and Design Dossiers * Experience in interventional cardiology, heart valve replacement, or stroke prevention and treatment therapies * Comprehensive understanding of medical device standards and guidance * Proficient understanding of regulations applicable to conduct of clinical trials * Excellent research and analytical skills * Strong leadership, interpersonal and influencing skills * Demonstrated ability to manage multiple regulatory projects, as well as serve as regulatory lead on projects * Ability to work independently with minimal supervision, as well as mentor/guide others * Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) Requisition ID: 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. Nearest Major Market: Minneapolis Job Segment: Cardiac, Regulatory Affairs, Medical, Law, Engineer, Healthcare, Legal, Engineering