Senior Regulatory Affairs Specialist

Why join AliveCor ?

At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG 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, millions of users have taken more than 200 million heart health measurements and counting.

Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we ve saved lives. Join us in our mission!

The Opportunity:

Senior Regulatory Affairs Specialist

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

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• 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

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• 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