Boston Scientific Principal Regulatory Affairs Specialist 

United States, Minnesota 

154353036

About the role:

This is a hybrid position (in office minimum three days per week) based in Maple Grove, Minnesota (preferred) or Marlborough, MA.

Your responsibilities will include:

• 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

Required qualifications:

• 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

Preferred qualifications:

• 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

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.