<link id='css--app'rel="stylesheet" href="/dist/css/app.min.css"> Opportunities – Trilogy

Opportunities

Regulatory Affairs Associate (Part Time - Entry Level) at Owlet Baby Care
Remote

This position is a short term entry-level learning opportunity for individuals considering future employment in Regulatory Affairs.  The individual will be trained to support select worldwide medical device product registrations and product compliance. This position will work cross functionally with product development teams to ensure that global regulatory requirements are addressed in the design. This position will work closely with quality and marketing to support license renewals, new product registrations, and product change registrations. 

 

Primary Responsibilities:

  • Responsible to assist the Regulatory Affairs team with formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations
  • Responsible for support in drafting Owlet regulatory paperwork including Technical Documentation for EU and UK, 510(k) documentation, Q-subs and other regulatory paperwork supporting Owlet’s medical device strategy
  • Responsible for review of design inputs to ensure applicable regulatory requirements have been identified to support US and international registrations
  • Responsible for support in the preparation of documentation required to support US and global registrations for license renewals, new product registrations, and product change registrations. Collaborate with Product, Engineering, Quality, and other applicable departments, as needed
  • Responsible for providing development teams with regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions
  • Responsible to assist with post-market activities including post-market surveillance, adverse event reporting, and field actions
  • Responsible for managing tools to support collaboration and execution of global regulatory strategies
  • Responsible for review of new regulations and development of internal compliance procedures
  • Responsible to assist in the review of protocols to assure collection of data for regulatory submissions and regulatory compliance, as needed
  • Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies, as needed

 

Required Skills and Qualifications:

  • High level understanding of US, EU and/or other Medical Device Regulations
  • High level knowledge of ISO13485 quality system requirements
  • Engineering student with proven technical capabilities preferred

 

 

Perks:

  • Flex time scheduling
  • Competitive compensation based on experience
  • Benefits package
  • Product discounts

 

Owlet Baby Care, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.