Senior Regulatory Affairs Specialist
Job Summary
Job Description
AliveCor seeks a Senior Regulatory Affairs Specialist to oversee medical device development and market introduction. Responsibilities include collaborating on global registration strategies (US, Europe, etc.), preparing regulatory submissions, managing FDA interactions, developing regional regulatory strategies, reviewing advertising materials, and providing regulatory support throughout the product lifecycle. This role requires experience with US FDA, EU MDR, NMPA, PMDA, and ANVISA compliance, managing product registrations worldwide, conducting regulatory assessments, and ensuring ISO 13485 and FDA compliant QMS. The ideal candidate will have a strong understanding of medical device regulations, particularly for software devices with AI/machine learning algorithms (SaMD).
Must have:
- 4+ years medical device regulatory affairs experience
- Experience with SaMD regulatory affairs
- 510(k) or De Novo submission experience
- EU MDR knowledge
- Global regulatory strategy execution
Good to have:
- Advanced degree or RAPS certification
- International submission experience (Asia-Pacific/LATAM)
- Technical documentation and communication skills
Perks:
- Hybrid work model
- Flexible vacation policy
- Maternity/Paternity leave
- Generous medical benefits
- Metro connectivity
3 skills required
Job Details
At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.
AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you.
Role & Responsibilities
- Collaborate and execute regulatory strategies for US, Europe and other global registrations
- Participate in preparation and review of global regulatory submissions
- Support government/FDA interactions pertaining to medical device registrations and licensing;
- Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes;
- Assist in the review of advertising and promotional materials;
- Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle;
- Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance;
- Support worldwide resellers and distributors with product registrations and renewals;
- Provide regulatory assessment for manufacturing and design changes;
- Provide regulatory review and approval of change order packets;
- Support or lead product regulatory intelligence and risk assessments;
- Assist in maintaining compliance with product post market requirements;
- Support post-market regulatory actions taken for the products;
- Support internal and external audits;
- Ensure compliance with internal procedures and external regulations and standards;
- Maintain regulatory and quality records and other controlled documents; and
- Promote a culture of quality throughout AliveCor
Requirements
- Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving
- 4+ years of experience in medical device Regulatory Affairs
- Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD)
- Participated in the preparation of pre-submissions, 510(k)s or de novo submissions
- Experience with and knowledge of EU Medical Device Regulations
- Ability to manage small projects: organised, independent, and results-oriented
- Superb analytical and excellent communication skills, strong team ethic, and attention to detail
Preferred candidate profile
- Advanced degree or Regulatory Affairs Certification from RAPS
- Process-oriented thinking
- Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM)
- Demonstrated competence documenting technical information and communicating it to others
Perks and benefits
We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.
- Hybrid working model
- Flexible and generous vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents
- Metro connectivity from office
- A supportive, collaborative group of people who understand that success depends on the team
AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law.
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