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Opportunities

Regulatory Compliance Specialist I at Owlet Baby Care
Lehi, UT, US

SUMMARY:

Owlet’s Regulatory Compliance Specialist will be the strategic and tactical lead for Owlet’s efforts associated with developing and sustaining Owlet’s compliance needs. This includes owning and driving processes to manage compliance with current standards, anticipation of and planning for new regulatory developments, updates and expectations, as well as reportability requirements for Owlet products and markets.

PRIMARY RESPONSIBILITIES:

  • Work cross functionally with Sales, Marketing, Supply Chain, Sourcing and Product groups to drive a compliance road map for current and future Owlet Products
  • Research regulations, assemble summaries, present findings, and formulate action plans for new and existing products, and markets to develop a compliance plan
  • Create registration and periodic renewal requirements for standard testing on Owlet products
  • Coordinate compliance testing with certified third-party labs
  • Track updates to regulations/standards governing Owlet products to ensure Owlet is up to date with changes and new regulations/standards
  • Research and develop reportability requirements for all Owlet products and markets
  • Develop and enforce Owlet’s Materials compliance policy and work with Sourcing, Product and Supply Chain teams to ensure compliance
  • Train internal customers on new and updated regulations, standards, etc.
  • Manage labeling requirements for all Owlet products and markets to ensure compliance
  • Standardize and develop processes, procedures and work instructions for compliance management
  • Complete documentation and technical reports for external customers
  • Support 510(k) documentation, Q-subs, and other regulatory paperwork for any MD products
  • Assist in the coordination of MD compliance testing and compliance reviews.

REQUIRED SKILLS AND QUALIFICATIONS:

  • B.S. or higher with 1-3 years’ experience
  • Associates degree with 3-5 years’ experience
  • Experience with International regulations and standards, or other exposure to legal, regulatory, etc. disciplines
  • ISO 13485 and/or ISO 9001 experience preferred
  • Detail oriented and well organized
  • Ability to work with cross-functional teams
  • Ability to act independently to solve complex problems
  • Experience writing procedures, and training others
  • Excellent decision-making skills

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.