Regulatory Affairs Specialist II – ElectrophysiologyNeuroTech X | Arden Hills, MN, US
Posted a month ago
Regulatory Affairs Specialist II – Electrophysiology
Legal and Regulatory · Arden Hills, MN, US · Full time
Boston Scientific’shybrid workplace includes remote and onsiteroles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Remote Eligible: Hybrid
Onsite Location(s): Arden Hills, MN, US, 55112
Additional Location(s): N/A
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.
About the role:
This role will be responsible for working on Boston Scientific’s most recently acquired novel Atrial Fibrillation technology, Pulsed Field Ablation (PFA) (FARAPULSE, Inc.). The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications. With adequate supervision, the Regulatory Affairs Specialist II 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.
Your responsibilities will include:
- 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 3 years work experience in regulatory affairs or a combination of experience from a related field (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry
- Bachelor’s Degree inlife sciences, engineering, 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
- 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
- Works well in fast-paced cross-functional team environments
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
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.
Nearest Major Market:Minneapolis
Job Segment: Medical Device, Compliance, Regulatory Affairs, International Health, International Medicine, Healthcare, Legal
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