Boston Scientific Senior Regulatory Affairs Specialist 

United States, Minnesota 

690700559

Senior Regulatory Affairs Specialist

This is a hybrid role (in office 3 days per week) based in Maple Grove, Minnesota.

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products
• Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Works cooperatively with R&D, process development, quality, manufacturing, biocompatibility, clinical, and marketing on complex projects to ensure success
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Tracks key competitive technologies and provides regulatory assessment in collaboration with new business development and marketing in order to gain alignment with franchise stakeholders
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams

Required Qualifications:

• Bachelor’s degree in a scientific or technical discipline, preferably a BS or MS in Engineering or Biological Sciences
• 5+ years Medical Device Regulatory Affairs experience, or 1+ years Medical Device Regulatory Affairs experience and 5+ years of experience in a related discipline within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Thorough understanding of US and EU medical device regulations
• Thorough understanding of product development process and design controls
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• 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
• Demonstrated ability to manage multiple regulatory projects, as well as serve as regulatory lead on projects
• Strong technical knowledge of medical devices, procedures, practices, and related terminology

Preferred Qualifications:

• Experience in interventional cardiology, strong clinical acumen, experience with PMDA submissions (JP)
• Comprehensive understanding of medical device standards and guidance
• Excellent research and analytical skills
• Excellent organizational, communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Strong leadership, interpersonal and influencing skills
• Ability to work independently with minimal supervision, as well as mentor/guide others
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

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.