Principal Regulatory Affairs Specialist

Boston Scientific-posted 3 months ago

$99,100 - $188,300/Yr

Full-time • Mid Level

Hybrid • Maple Grove, MN

5,001-10,000 employees

Merchant Wholesalers, Durable Goods

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This role, within the Interventional Oncology and Embolization division, is responsible for a wide variety of projects and regulatory strategy in early stage, new product development. This includes strategic support for Boston Scientific's TheraSphere products. This role provides an opportunity to gain regulatory experience in US, and EU, and other international regions. This is a hybrid position (in office minimum three days per week) based in Maple Grove, Minnesota (preferred) or Marlborough, MA.

Lead and represent RA on cross functional projects in new product development and may include manufacturing process changes
Develop domestic and international strategies for regulatory approval of Class II and III medical devices. This includes strategies for IDE approvals in the US.
Coordinate, compile, and submit US regulatory filings for new and modified products, including IDEs, IDE Supplements, PMAs, PMA Supplements, pre-submissions, 510(k)s, PMA & IDE Annual Reports
Support EU submissions for new clinical trials
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Technical and labeling reviews of supporting documents for inclusion in regulatory filings
Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
Develop and maintain positive relationships with regulatory agency staff
Lead and/or participate in regulatory audits, as required

Minimum of a Bachelor's Degree
7+ years of experience in Regulatory Affairs or 5+ years of experience in Regulatory Affairs with other relevant experience
Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects
Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing and business strategies for global product commercialization
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as IDEs, pre-submissions, original PMAs, PMA Supplements, 510(k)s, and MDR Technical Documentation
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, healthcare or related field
Previous experience in the medical device industry with Class II and III device submissions
Experience working directly with FDA, notified bodies and/or international health authorities
Demonstrated leadership, strategic thinking, project planning, and project management skills
Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies
Able to work independently with minimal supervision
Strong technical, research and problem-solving skills
Demonstrated ability to mentor junior regulatory staff members to aid in their development
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

401k
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