Boston Scientific Principal Regulatory Affairs Specialist 

United States, Massachusetts, Waltham 

589565999

This is a hybrid role (in office 3 days per week) based in Waltham, Massachusetts or Arden Hills, Minnesota.Your responsibilities will include:

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
• Represents Regulatory Affairs on cross functional projects which may include new product development, design/manufacturing changes, and continuous improvement efforts
• Develops regulatory strategies for Class II and III electronic medical equipment devices
• Coordinates, compiles, and submits US 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
• 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
• 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
• Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
• 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 CE Design Dossiers, Tech Files, and MDR Tech Docs
• 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:

• Experience working directly with FDA, notified bodies and/or international health authorities
• Prior experience with electrophysiology and/or capital equipment/software devices
• Able to work independently with minimal supervision
• Demonstrated leadership, strategic thinking, project planning, and project management 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
• Prior experience providing technical guidance, training, and/or mentoring to Regulatory Affairs and/or cross-functional peers

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.