- Prepare, submit, and update pre-submission packages, Q-sub/supplements/amendments & RA submission pathways compliant with 21CFR820, 21CFR892, and FDA guidance documents
- Prepare justifications for intended use, risk classifications, and substantial equivalence matrix
- Perform regulatory impact assessments of design changes
- Collaborate with cross-functional teams to develop DHF/RMF/DMR alongside SaMD development sprints
- Assist in developing eQMS processes, procedures, work instructions, and forms for the Regulatory department
- Develop eQMS for DHF/RMF/DMR, cybersecurity, software development, and app development
- Support front-room, desk audits, and site inspections by regulatory authorities
- Review, comment on, and approve change control requests affecting medical device marketing
- Complete letters to file following US FDA regulations and guidance
- Build and nurture relationships with external authorities, including US FDA, Health Canada, and Notified Bodies
- Complete all required training and maintain training plans and records
- Complete regional regulatory authority requests and provide requested documents
- Review, comment on, and approve labeling change requests, advertising, promotional requests, and field communications
- Execute, manage, and close post-market activities, including complaints, recalls, and corrections
- Prepare and submit all reporting activities associated with removals or corrections to US FDA and associated OUS Competent Authorities
- Assess standards changes and the impact of new and revised regulatory requirements
- Complete inquiries and requests from internal and external sources regarding regulatory processes and practices
- Support supervisor with any other requests for information and documentation associated with regulatory laws and regulations
- Bachelor of Science, Engineering, or Medical Technology
- Regulatory Affairs Certification (RAC) preferred
- Minimum of 5 years of international experience in medical device Regulatory Affairs
- Experience with Class I, II medical devices, MDDS, and CDS
- Authorship and implementation of a minimum of 20 standard operating procedures
- Experience managing post-market actions in the US
- Familiarity with FDA electronic submission platforms (e.g., eSTAR, FURLS)
- Experience with US/EU/Canada submissions
- Deep understanding of global regulatory standards and frameworks, including IEC 62304, 21CFR820, ISO 13485, ISO 14971, IEC 62366, FDA guidances, European MDR, Health Canada Medical Device regulations, and State/Provincial RA regulations
- Familiarity with regulatory requirements for medical device software, AI/ML-enabled devices, predetermined change control plans, and cybersecurity
- Proficiency in Quality System Regulations ISO 13485, recalls and corrections, and labeling requirements, with international experience being desirable
- Understanding of Class I, II medical devices, MDDS, and CDS
- Knowledge of FDA Q-submissions and electronic submission processes, as well as US/EU/Canada submissions processes
- Self-starter with strong independent work capabilities
- Effective time management and problem-solving skills
- Excellent interpersonal and collaborative abilities.
- Proficiency in conducting thorough research on regulatory requirements and executing end to end project-based tasks with tight deadlines
- Strong analytical skills and sound judgment
- Demonstrated organizational proficiency
- Clear and concise oral and written communication skills.
- Experience with ISO-27001
- Experience with UDI/Eudamed requirements
- We empower - We are all agents for change in transforming healthcare and in transforming our health
- We work together - We work together to support and deliver the best for our members and ourselves
- We bring transparency - Positive change comes from transparency in where we stand as a company, as colleagues and as Prenuvo members
- An avenue to make a positive impact on people's lives and their health
- We believe in preventative healthcare for everyone, including our team - Prenuvo provides free, whole-body scans to each team member
- Growth opportunities are at the heart of our people journey, we're doing big things with bright minds - there is no single path to success, it can be shaped along the way
- Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize
- Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it
- We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family
- The base salary offered for this position is $65,000 - $80,000 in local currency
-
Regulatory Compliance Specialist
1 week ago
SPORTS RESEARCH CORPORATION San Pedro, United States**Company**:Sports Research · **Job Title**: Regulatory Compliance Specialist · **Location**: Corporate Office - 784 Channel Street, San Pedro, CA 90731 · **Hybrid Remote**:Work from home Thursdays · **Starting Rate**: $30.00 per hour · **About Us**: · - Sports Research is a lead ...
-
Regulatory Specialist
5 days ago
Prenuvo San Francisco, United StatesJob Description · Job Description · Candidates located in the US/Canada (where we have clinic locations) are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver. · ...
-
Regulatory Specialist
14 hours ago
Prenuvo San Francisco, United StatesCandidates located in the US/Canada (where we have clinic locations) are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver. · About Us · At Prenuvo, we are on a m ...
-
Regulatory Specialist
2 days ago
Prenuvo San Francisco, United StatesJob Description · Job DescriptionCandidates located in the US/Canada (where we have clinic locations) are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver. · About ...
-
Regulatory Specialist
1 week ago
Prenuvo San Francisco, United StatesJob Description · Job DescriptionCandidates located in the US/Canada (where we have clinic locations) are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver. · About ...
-
Regulatory Affairs Specialist
3 weeks ago
Synergy Solutions Hercules, United StatesEssential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...
-
Regulatory Compliance Specialist
3 weeks ago
Tailored Management San Francisco, United StatesJob Title: Regulatory Compliance Specialist · Location: 888 Brannan Street, San Francisco, CA 94103 · Compensation: $29.50/hr · Schedule: Available 40 hrs./week June-July 2024 · Duties: · The Legal team at Airbnb embodies the company's innovative and entrepreneurial spirit. Airbn ...
-
Specialist, Regulatory Affairs
3 weeks ago
Knewin San Francisco, United StatesAbout Pendulum · Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + pr ...
-
Specialist, Regulatory Affairs
3 days ago
Pendulum San Francisco, United StatesAbout Pendulum · Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + pre ...
-
Regulatory Compliance Specialist
2 weeks ago
Tailored Management San Francisco, United StatesJob Title: Regulatory Compliance Specialist · Location: 888 Brannan Street, San Francisco, CA 94103 · Compensation: $29.50/hr · Schedule: Available 40 hrs./week June-July 2024 · Duties: · The Legal team at Airbnb embodies the companys innovative and entrepreneurial spirit. A ...
-
Regulatory Compliance Specialist
1 week ago
Tailored Management San Francisco, United StatesJob Title: · Regulatory Compliance Specialist · Location: · 888 Brannan Street, San Francisco, CA 94103 · Compensation: · $29.50/hr · Schedule: · Available 40 hrs./week June-July 2024 · Duties: · The Legal team at Airbnb embodies the company's innovative and entrepreneurial ...
-
Regulatory Compliance Specialist
1 week ago
Tailored Management San Francisco, United StatesJob Title: Regulatory Compliance SpecialistLocation: 888 Brannan Street, San Francisco, CA 94103Compensation: $29.50/hrSchedule: Available 40 hrs./week June-July 2024Duties:The Legal team at Airbnb embodies the companys innovative and entrepreneurial spirit. Airbnb continues to b ...
-
Regulatory Compliance Specialist
3 weeks ago
ICONMA San Francisco, United StatesTop 3 Daily Responsibilities: · Supporting the Regulatory Compliance team's management of submitting required collision reports to CA and federal regulators, including the collection of internal data, writing of narratives of collision events, fact-checking, and quality controll ...
-
Regulatory Compliance Specialist
3 weeks ago
ICONMA San Francisco, United StatesTop 3 Daily Responsibilities:Supporting the Regulatory Compliance team's management of submitting required collision reports to CA and federal regulators, including the collection of internal data, writing of narratives of collision events, fact-checking, and quality controlling ...
-
Regulatory Affairs Specialist-4694
2 weeks ago
Infosoft Palo Alto, United StatesOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
-
CMC Regulatory Affairs Specialist
5 days ago
Spectraforce Technologies Inc San Francisco, United States PermanentJob title: CMC Regulatory Technical Writer II · Location: Bridgewater, NJ, Hybrid · Duration: 1 year · SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri · Pay Rate starts: $47/ HOUR · HM Notes: · Hybrid - onsite Tuesday & Thursday - This can change at any time. · 5 years exper ...
-
Regulatory Affairs Specialist(W2 Only)
2 weeks ago
Infosoft Teksolutions Palo Alto, United StatesHere are the job position details for your review: · Job Title**:Regulatory Affairs Specialist (W2 Only)** · Pay Rate**:$63 to $68.89/HR** · Duration**:12 months** · Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** · **Must have skills on the Resume**: · - **Product Regis ...
-
Regulatory Specialist
3 weeks ago
Planet Pharma Alameda, United StatesDuties: · Responsible for implementing and maintaining the effectiveness of the quality system. · Supports manufacturing/operations day to day activities for change control. · Provides consultation/advice to regulatory specialist for change control and product development. · Prov ...
-
Regulatory Specialist
3 weeks ago
GForce Life Sciences Alameda, United StatesRegulatory Affairs Specialist II On-site in Alameda, CAQualificationsBS in Life Sciences or Medical Engineering/Technology5+ years of professional experience (not internship experience)Medical device experience requiredNeeds to have the skill set and able to hit the ground runnin ...
-
Regulatory Specialist
2 weeks ago
GForce Life Sciences Alameda, United StatesRegulatory Affairs Specialist II – On-site in Alameda, CA · Qualifications · BS in Life Sciences or Medical Engineering/Technology · 5+ years of professional experience (not internship experience) · Medical device experience required · Needs to have the skill set and able to hit ...
Regulatory Specialist - San Francisco, United States - Prenuvo
Description
Candidates located in the US/Canada (where we have clinic locations) are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver.About Us
At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience of our clinics across North America, have allowed us to lead the charge against "we caught it too late again." Prenuvo operates preventative screening clinics in Vancouver, Silicon Valley, Dallas, Boca Raton, Minneapolis, Los Angeles, New York City, Bethesda, and Chicago, with more clinics in North America and internationally in the next 2 years.
The Opportunity
We are changing healthcare and bringing a slow moving goliath of an industry into the present while blazing a trail into the future of radiology and clinical operations through software, automation and AI. We are looking for a Regulatory Affairs Specialist to support global pre and post market matters including regulatory submissions in all target jurisdictions as defined by our corporate strategy.
Reporting to the Head of Regulatory Affairs & Quality, the Regulatory Affairs Specialist will support global pre and post market matters including regulatory submissions, medical device software design reviews, product releases, deviation management and change control activities, product promotional activities, labeling review activities, product registration and listing databases, global product registrations requests, and post market actions. The RA Specialist will ensure regulatory compliance of Prenuvo's product portfolio including SaMD/MDDS/CDS for advanced medical imaging technology and innovative AI/ML-enabled medical devices, in all target jurisdictions as defined by our corporate strategy.
Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives
Candidates located in the US/Canada are welcome to apply. Seize the opportunity to work in a role that offers the flexibility of remote work, with occasional travel to our vibrant headquarters in Vancouver.
What You'll Do
Regulatory Submissions:
As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, state and provincial rules.
