Job Description

Job Title: Regulatory Affairs Senior Specialist

Job Location: Boston, MA, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

As a Regulatory Affairs Senior Specialis t, you'll be at the heart of our mission to enrich and save lives through technology and meaningful connections. By ensuring our wearable monitoring device meets global regulatory standards, you'll help enable care at home for everyone. You'll prepare and submit crucial filings like 510(k), EU MDR Technical Documentation, and UKCA submissions, maintain essential regulatory documentation, and support compliance with ISO 13485:2016, FDA QSR 820, EU MDR 2017/745, and UK MHRA. Staying ahead of regulatory changes, you'll keep internal stakeholders informed and provide vital regulatory input during product development and design reviews. Your role is essential in maintaining our product's regulatory integrity throughout its lifecycle, making a real 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

• Assist in preparing and submitting regulatory filings, such as 510(k), EU MDR Technical Documentation, UKCA submissions, and other international registrations.
• Maintain regulatory documentation, including technical files, risk management files, and labeling documentation.
• Support compliance with ISO 13485:2016, FDA QSR 820, EU MDR 2017/745, UK MHRA, and other applicable regulations.
• Monitor changes in regulatory requirements and update internal stakeholders as needed.
• Provide regulatory input during product development and design reviews to ensure compliance with applicable standards.

Basic Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline is required
• Minimum of 3 years of experience in regulatory affairs within the medical device industry required
• Minimum of 3 years regulatory submissions in regions such as the US, EU, and UK required
• Experience with ISO 13485:2016, FDA QSR 820, and EU MDR 2017/745 standards required
• Exposure to audits, inspections, and regulatory authority interactions required
• 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

• Familiarity with software as a medical device (SaMD) and digital health technologies preferred
• Additional certification or training in regulatory affairs 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 .

To learn more about, view the “Know Your Rights” poster and Pay Transparency Nondiscrimination Provision HERE.

Position Type: Full timePandoLogic. Keywords: Regulatory Compliance Specialist, Location: Boston, MA - 02210

Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

Job Tags

Full time, Contract work, Remote job,

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