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Opportunities

Senior Regulatory Affairs Specialist at Owlet Baby Care
Lehi, UT, US

This position has overall Regulatory Affairs responsibility for providing oversight and support for worldwide medical device product registrations. This position is also responsible for providing input to product development teams to ensure global regulatory requirements are addressed. This position will work closely with product teams to support license renewals, new product registrations, and product change registrations. 

Primary Responsibilities:

  • The Senior Regulatory Affairs Specialist will 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 drafting all Owlet regulatory paperwork including 510(k) documentation, Q-subs and other regulatory paperwork supporting Owlet’s medical device strategy
  • Responsible for reviewing design inputs to ensure applicable regulatory requirements have been identified to support US and international registrations
  • Responsible for leading and coordinating 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
  • Assist with post-market activities including post-market surveillance, adverse event reporting, and field actions
  • Lead the follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars.
  • Responsible for managing tools to support collaboration and execution of global regulatory strategies
  • Participate in the review of new regulations and development of internal procedures
  • Responsible for reviewing protocols to assure collection of appropriate 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:

  • B.S. degree or higher
  • 5+ years of Regulatory Affairs experience in the medical device industry
  • Demonstrated experience with 510(k) clearance or Denovo clearance required
  • Experience with international product registrations
  • Working knowledge of worldwide regulations, policies, and procedures
  • Working knowledge of industry consensus standards
  • Strong written and verbal communication skills
  • High scientific and analytical evaluation skills
  • Proficient in with FDA, Health Canada, ISO, OSHA, RoHS, REACH, UL, GMP, UDI, and ISO13485 requirements
  • Regulatory Affairs Certified RAC (RAPS) preferred

Evaluation Criteria:

Owlet employees participate in quarterly evaluations that include:

  • Performance feedback
  • Behavioral feedback
  • Training and development opportunities
  • Manager feedback

Perks:

  • Competitive compensation based on experience
  • Flexible schedules
  • Paid holidays
  • Product discounts
  • 401(k) program with company match
  • Eligible for company-sponsored benefits package 1st day of the month, following your hire date

 

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.