- Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
- Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
- Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
- Develops and maintains positive relationships with regulatory body reviewers
- Technical and labeling reviews of supporting documents for inclusion in regulatory filings
- Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
- Support regulatory audits, as required
- A minimum of a bachelor's degree or equivalent work experience
- A minimum of 5 years work experience in regulatory affairs or related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices, pharmaceutical, or health care industry
- Working knowledge of relevant US/EU and/or International regulatory requirements for medical devices including Quality Systems standards
- Effective written and oral communication, technical writing and editing skills
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Bachelor's Degree in life sciences, engineering, computer science or related field
- Previous experience with Class II or III medical devices submissions
- Experience working directly with FDA, notified bodies and/or international health authorities
- Experience working with Medical Electrical Equipment (MEE) and related IEC 60601 standards
- Experience working with medical device software
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Sr. Regulatory Affairs Specialist - Arden Hills, United States - Boston Scientific
Description
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.
You'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer diagnostic and treatment solutions for treating irregular heart rhythms and heart failure. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.
About the role:
Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.
As a Senior Regulatory Affairs Specialist within the Digital Health and Cardiac Diagnostics Regulatory team at Boston Scientific CRM, you will have the opportunity to support bringing state of the art life sustaining and life-saving technologies to patients worldwide.
Your responsibilities will include:
Required qualifications:
Preferred qualifications:
Requisition ID: 577566
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 prohibited substance free workplace. Pursuant to Va. Code § , 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.
