POSITION TITLE: Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist

DEPARTMENT: Quality & Regulatory

LOCATION: Remote, U.S.

SUMMARY:

Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world by bringing joy, peace and sleep to the parenting journey. Owlet has helped more than a million parents keep their children safe. We are focused on helping parents take care of their little ones so we can keep every baby safe and healthy.

The Regulatory Affairs Specialist / Senior Regulatory Affairs Specialist is responsible for acting as the regulatory representative to support product development and regulatory compliance across Owlet’s product portfolio, with a particular focus on wearable medical device technology and consumer electronics. This position will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product registrations. The level of seniority for this role, whether Specialist or Senior Specialist, will be determined based on the candidate's experience and qualifications.

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 (i.e. Technical Documentation for EU and UK, 510(k) documentation, Q-subs and other regulatory paperwork)
• Responsible for the preparation of documentation and third party testing required to support US and global registrations for license renewals, new product registrations, and product change registrations. Collaborate with Sales, Product, and external partners, as needed
• Evaluate global regulatory landscape and contribute to providing internal advice to cross functional teams throughout the product lifecycle to ensure product compliance
• Responsible for review of design inputs and proposed design changes to ensure applicable regulatory requirements have been identified to support US and international compliance requirements
• Review product labeling and promotional materials to ensure consistency with regulatory clearances
• Author and/or review DHF documentation to support Owlet’s global regulatory strategy
• Coordinate post-market activities including post-market surveillance, trend reporting, adverse event reporting, and field safety corrective actions
• Responsible for review of new/revised regulations/standards and the development of internal standard operating procedures (SOP), work instructions (WI), and policies, as needed
• Maintenance of regulatory databases and other public-facing information such as FDA establishment listings, GUIDID, and EUDAMED device registration
• Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards

REQUIRED SKILLS & QUALIFICATIONS:

• High level understanding of US, EU, Canadian and/or other global Medical Device Regulations
• High level knowledge of ISO 13485 quality system requirements
• Experience compiling and submitting regulatory applications and submissions
• Bachelor's degree in a STEM field and 3-5 years of experience in a regulatory affairs role in the medical device industry
• SaMD and/or wearable experience preferred
• Other compliance experience (i.e. EU RED, CPSC, FCC, REACH) preferred
• Must be detail-oriented with strong technical writing skills
• Must have the ability to think critically and strategically, capable of effectively interpreting and communicating the impact of business initiatives, regulations, and industry trends to various stakeholders
• Must possess strong interpersonal communication, teamwork, and organizational skills, able to build and leverage cross-functional relationships to gather insights and drive continuous improvement
• Must be an analytical problem solver, adept at identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues

PERKS

• Fully remote position
• Flex time scheduling
• Competitive compensation based on experience
• 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.