Principal Regulatory Affairs Specialist

Additional Location(s):US-MN-Maple Grove

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.

About this role:
This role, within the Peripheral Interventions division, is responsible for a wide variety of catheter, balloon, and implantable products that support Boston Scientific’s Clot Management and Carotid Therapy businesses. This includes strategic support of Boston Scientific’s Transcarotid Artery Revascularization (TCAR) technologies. TCAR is a cutting-edge, comprehensive carotid artery disease therapy designed for stroke prevention while exposing patients to less risk and pain.

This role provides opportunity to gain regulatory experience in US, China, Japan, and other international regions.

This is a hybrid role based in Maple Grove, Minnesota, requiring employees to be in our local office at least three days per week.

Your responsibilities will include:

• Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
• Develops domestic and international strategies for regulatory approval of Class II and III medical devices. This includes strategies for gaining CE Mark under EU MDR
• Coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k) s, PMA & IDE Annual Reports
• Supports international regulatory partners with commercial marketing applications and post-market studies
• 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
• Develops and maintains positive relationships with regulatory agency staff
  Lead and/or participate in regulatory audits, as required

Required qualifications:

• Minimum of a Bachelor's Degree
• 7+ years of experience in Regulatory Affairs, or 5+ years of experience with an advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline
• Demonstrated leadership, strategic thinking, project planning, and project management skills
• 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
• Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies
• 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 original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k) s, and MDR Technical Documentation
• Strong technical, research and problem-solving skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• 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…