What are the responsibilities and job description for the Regulatory Affairs Senior Specialist position at Lifelancer?
Job Title : Regulatory Affairs Senior Specialist
Job Location : Boston MA USA
Job Location Type : Remote
Job Contract Type : Fulltime
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
Preferred Qualifications
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 wellbeing and provide support as you need it especially key moments in your life.
Our Benefits Include
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 devicebased 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 preemployment 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 talenthiring 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.
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Key Skills
Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support
Employment Type : Full Time
Vacancy : 1
