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Job Search / Medical Device

Senior Regulatory Affairs Specialist

Job Details

Location
Mountain View , United States
Ref
1055
Contact
Colin Etheridge
Contact email
Email Colin
Contact phone
+1 628 400 4029
Posted
14 days ago

Senior Regulatory Affairs Specialist

My client we imagines 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. They’re on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. My client 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.

They seek 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.

Responsibilities:

  • Participate in preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities;
  • Support government interactions pertaining to medical device registrations and licensing;
  • Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes;
  • Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle;
  • Support regulatory activities required for EU MDR compliance;
  • Support worldwide distributors with product registrations and renewals;
  • Provide regulatory assessment for manufacturing and design changes;
  • Provide regulatory review and approval of change order packets;
  • Support product regulatory intelligence and risk assessments;
  • Assist in maintaining compliance with product post market requirements;
  • Support post-market regulatory actions taken for the products;
  • Assist in the review of advertising and promotional materials;
  • Support internal and external audits;
  • Ensure compliance with internal procedures and external regulations and standards;
  • Maintain and update quality system procedures;
  • Maintain quality records and other controlled documents;
  • Promote a culture of quality throughout the company; and
  • Other Regulatory and Quality duties as assigned.

Requirements:

  • Bachelor’s 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
  • Ability to manage small projects: organized, independent, and results-oriented
  • Superb analytical and excellent communication skills, strong team ethic, and attention to detail