Regulatory Affairs Senior Manager

3 weeks ago

Boston, United States Best Buy Health Careers Full time
As the Regulatory Affairs Senior Manager you will be responsible for staying up to date on emerging regulatory trends, policy changes, and other legislative updates as it relates to Best Buy Health’s products and services. In this role you will both communicate complex regulatory information in a clear and concise manner to a variety of technical and non-technical audiences, and provide expert guidance to translate complex regulatory requirements into actionable and practical strategies. As a strong candidate for this role you are someone who can effectively work across both US and UK time zones and are highly skilled in your ability to research, analyze and communicate complicated information in an easy to understand way.

This role is remote, which means you would work virtually from home or another US-based non-Best Buy Health location.

What you’ll do
  • Monitor and analyze emerging regulatory trends, legislative updates, and policy changes that may impact the medical device industry.
  • Conduct research and identify potential regulatory risks and opportunities for the company's medical devices.
  • Prepare comprehensive reports and presentations on regulatory intelligence for internal stakeholders (e.g., regulatory affairs managers, executive team).
  • Participate in industry events and conferences to stay current with regulatory developments.
  • Support the development of regulatory strategies by providing insights and analysis of the regulatory environment.
  • Liaise with regulatory agencies and industry associations to gather information and build relationships.
  • Develop and maintain a regulatory intelligence database to track key information.

Basic qualifications
  • Bachelor's degree in science, engineering, public policy or a related field required
  • Minimum of 7 years of experience in medical device regulatory affairs, policy analysis, or a related field required

Preferred qualifications
  • Master's degree in a science or engineering field preferred
  • Understanding of global regulatory landscapes for medical devices, including US (FDA), EU (MDR), and international regulations preferred
  • Familiarity with relevant standards for medical devices, such as ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745, MHRA preferred
  • Experience in SaMD and AI/ML preferred

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 HERE.

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 HERE.

Position Type: Full timePandoLogic. Category:Marketing & Biz Dev, Keywords:Compliance Manager, Location:Boston, MA-02108

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