- Supporting the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
- Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
- Supporting requests from BSC International Regulatory related to submissions, registrations, and change assessment
- Developing and maintaining positive relationships with regulatory body reviewers
- Technical and labeling reviews of supporting documents for inclusion in regulatory filings
- Reviewing of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Representing RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
- Supporting regulatory audits, as required
- A minimum of a Bachelor's Degree
- A minimum of 2 years work experience in regulatory affairs or a combination of 3 years experience from a related field (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device 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
- 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
- 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
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Regulatory Specialist II - Arden Hills, United States - Boston Scientific
Description
Recruiter: Spencer Gregory Hale
Regulatory Specialist II, Electrophysiology Pulsed Field Ablation, Regulatory Affairs
At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.
About this role:
This role will be responsible for working on Boston Scientific's most recently acquired novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. 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:
What we're looking for in you:
Required Qualifications
Preferred Qualifications
Requisition ID:580514
Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
