Regulatory Affairs Manager at Best Buy Health in Boston, Massachusetts

Job Description:

As the <strong>Regulatory Affairs Manager</strong> you will be responsible for ensuring the global regulatory compliance of medical devices throughout their lifecycle, from development to post-market surveillance. You will manage the regulatory approval process by interacting with agencies and ensure timely responses while building strong relationships with these agencies worldwide. Your role will also provide internal strategic guidance to cross-functional teams on regulatory requirements throughout product development. As a strong candidate for this role, you are someone with excellent analytical and communication skills and you thrive in an environment where you are accountable for managing multiple projects and deadlines. Because you will work with teams both in the US and UK you must be flexible to work across various time zones, including the UK.<br><br>This role is remote, which means you would work virtually from home or another US-based non-Best Buy Health location.<br><br><strong>What you'll do</strong><ul><li>Develop and implement comprehensive global regulatory strategies for new and existing medical devices, ensuring compliance with US (FDA), EU (MDR), and international regulations.</li><li>Lead the preparation and submission of regulatory filings for US (510(k), PMA), EU (CE Marking), and other international markets (as applicable).</li><li>Manage the regulatory approval process, interacting with regulatory agencies and ensuring timely responses to inquiries and requests.</li><li>Identify and manage regulatory risks associated with product development and commercialization.</li><li>Lead the development and implementation of post-market surveillance plans (PMS) in accordance with regulatory requirements.</li></ul><br><strong>Basic qualifications</strong><ul><li>Bachelor's degree in science, engineering, or a related field required</li><li>Minimum 6 years of experience in medical device regulatory affairs, with a focus on global regulatory strategies and submissions required</li></ul><br><strong>Preferred qualifications</strong><ul><li>Master's degree in a science or engineering field preferred</li><li>Certified Regulatory Affairs Professional or RAPS certification preferred</li><li>Proven experience in developing and implementing regulatory strategies for medical devices with both hardware and software components preferred</li><li>In-depth knowledge of US (FDA QSR 820), EU (MDR 2017/745, MHRA), and international regulatory requirements for medical devices preferred</li><li>Understanding of ISO 13485:2016 and ISO 14971:2019 as they pertain to regulatory submissions preferred</li><li>Experience in SaMD and AI/ML preferred</li></ul><br><strong>What's in it for you</strong><br>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.<br>Our benefits include:<ul><li>Physical and mental well-being support via Best Buy Health Wellness Program</li><li>Comprehensive benefits including tuition reimbursement, caregiver support, and more</li><li>Generous Best Buy employee discount</li></ul><br><strong>About us</strong><br><br>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.<br><br><br>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 <a href="https://sn.bestbuy.com/myhr?id=kb_article&sysparm_article=KB0207591" target="_blank">HERE</a>.<br><br><strong>Reasonable Accommodation</strong><br><br>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.<br><br>To learn more about, view the "Know Your Rights" poster and Pay Transparency Nondiscrimination Provision <a href="https://sn.bestbuy.com/myhr?id=kb_article&sysparm_article=KB0207598" target="_blank">HERE</a>. <p> Position Type: Full timePandoLogic. Keywords: Compliance Manager, Location: Boston, MA - 02108