- Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
- Researches and advises company on country specific international product registration and compliance related requirements
- 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 international regulatory partners with investigational device and commercial marketing applications
- Develops and maintains positive relationships with regulatory agency staff
- 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, site transfers, and continuous improvement efforts
- Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
- Review and approval of marketing materials
- Lead and/or participate in regulatory audits, as required
- A minimum of a Bachelor's Degree
- A minimum of 8 years of regulatory affairs or related experience, or 5 years' experience with an advanced degree (Masters or PhD)
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
- Able to work independently with minimal supervision
- Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
- Demonstrated leadership, strategic thinking, project planning, and project management skills
- Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
- Strong technical, research and problem-solving skills
- Able to work well in fast-paced cross-functional team environments
- Ability to articulate complex ideas clearly both verbally and in writing
- Demonstrated ability to develop strong relationships with regulatory agency staff
- Demonstrated ability to effectively lead multiple regulatory projects and priorities
- 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, or related field
- Previous experience in the medical device industry with Class II or III device submissions
- Experience working directly with FDA, notified bodies and/or international health authorities
- Prior experience with electrophysiology and/or medical electronic equipment products
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Principal Reg Affairs Specialist - Arden Hills, United States - Boston Scientific
Description
Recruiter: Spencer Gregory Hale
Principal Reg Affairs Specialist
About the role:
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.
This role will be responsible for working on Boston Scientific's 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 and recently received PMA approval in the US. 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.
Under minimal supervision, the Principal Regulatory Affairs Specialist is responsible for developing regulatory strategy, planning, managing, and implementing regulatory approvals in the US and EU, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Your responsibilities will include:
What we're looking for in you:
Required qualifications:
Preferred qualifications:
Requisition ID:581430
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
