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
