Regulatory Affairs Director

Company: Best Buy Health
Location: Boston
Posted on: February 12, 2025

Job Description:

As a Regulatory Affairs Director, you'll be instrumental in our mission to transform lives through technology and meaningful connections. Leading our regulatory function, you'll ensure our wearable monitoring device meets global standards, enabling care at home for everyone. You'll craft and implement impactful regulatory strategies, manage critical submissions like 510(k) and EU MDR Technical Documentation, and maintain compliance with ISO 13485:2016, FDA QSR 820, EU MDR 2017/745, and UK MHRA. Your leadership will guide interactions with regulatory agencies, mentor a dedicated team, and keep us ahead of regulatory changes. By fostering a culture of excellence, you'll drive successful market entry and sustain compliance, making a profound difference in people's lives.

This role is remote but may involve occasional onsite collaboration at our Best Buy Health hub. For this role, you must be located within a commutable distance to either the Boston MA, Minneapolis MN or San Antonio TX office. Current Best Buy Health and Best Buy employees are encouraged to apply, regardless of location. The recruiter or hiring manager will provide more details during the hiring process.

What you'll do

• Prepare and manage regulatory submissions, including 510(k), EU MDR Technical Documentation, UKCA submissions, and other global filings.
• Develop and execute regulatory strategies to support product development, approvals, and market access in both software as a medical device (SaMD) and other digital health technology landscapes.
• Lead, manage, and mentor regulatory affairs team members.
• Ensure compliance with ISO 13485:2016, FDA QSR 820, EU MDR 2017/745, UK MHRA, and other applicable standards and regulations.
• Lead interactions with regulatory agencies and notified bodies, acting as the primary contact for audits, inspections, and inquiries.
• Maintain a robust knowledge of changing regulatory landscapes and communicate updates to internal stakeholders.
  Basic qualifications
  • Minimum of 10 years of experience in regulatory affairs within the medical device industry required
  • Proven track record in obtaining regulatory approvals in multiple regions, including the US, EU, and UK required
  • Extensive experience with ISO 13485:2016, FDA QSR 820, EU MDR 2017/745, and other global regulatory standards required
  • Demonstrated experience in managing regulatory aspects of medical devices, including wearables or digital health technologies.
  • Strong background in pre-market submissions, regulatory compliance, and post-market surveillance activities.
  • For this role, you must be located within a commutable distance to either the Boston MA, Minneapolis MN or San Antonio TX office. Current Best Buy Health and Best Buy employees are eligible regardless of location
    Preferred qualifications
    • Proven ability to develop and execute regulatory strategies for innovative medical devices.
    • Strong leadership and interpersonal skills, with experience in team management and cross-functional collaboration.
    • Excellent written and verbal communication skills, with the ability to present complex regulatory concepts to diverse audiences.
    • Proficiency working with electronic submission platforms.
      What's in it for you
      We're committed to helping our people thrive at work and at home. We offer generous benefits that address your total well-being and provide support as you need it, especially key moments in your life.
      
      Our benefits include:
      • Physical and mental well-being support via Best Buy Health Wellness Program
      • Comprehensive benefits including tuition reimbursement, caregiver support, and more
      • Generous Best Buy employee discount
        About us
        
        Best Buy Health aims to enrich and save lives through technology and meaningful connections. Our strategy focuses on three main areas: consumer health products that help customers live healthier lives, device-based emergency response services for the active aging population, and virtual care offerings that help to connect patients and physicians.
        
        
        Best Buy Health is an Affirmative Action and Equal Opportunity Employer dedicated to creating an inclusive environment that values the diversity of our employees and does not discriminate against any employee or applicant. We are committed to equal employment opportunity for all applicants and employees, without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other protected characteristic under applicable law. Learn more about our Affirmative Action Policy Statement .
        
        Reasonable Accommodation
        
        Best Buy Health will make reasonable accommodations for employees and applicants for their religious beliefs and practices, mental or physical disabilities, and pregnancy, childbirth and related conditions. If you need a reasonable accommodation in the application process - to access job postings, to apply for a job, for a job interview, for pre-employment testing or with the onboarding process - please contact Talent Acquisition at talent.acquisition@bestbuy.com.
        
        To learn more about, view the "Know Your Rights" poster and Pay Transparency Nondiscrimination Provision . Position Type: Full timePandoLogic. Category:Marketing & Biz Dev, Keywords:Compliance Director, Location:Boston, MA-02108

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