Regulatory Affairs Specialist II

Owletcare; Wisconsin; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a Regulatory Specialist II to join their dynamic team. This role focuses on supporting product development and ensuring regulatory compliance for wearable medical devices and consumer electronics. With a strong emphasis on collaboration, you will work closely with cross-functional teams to navigate the complexities of global regulations and contribute to the company's mission of enhancing parenting experiences. If you're detail-oriented and passionate about regulatory affairs, this is a fantastic opportunity to make a meaningful impact in a rapidly evolving industry.

Benefits

Fully remote position

Competitive compensation based on experience

Qualifications

• 3+ years in medical device industry with regulatory experience.
• Detail-oriented with strong technical writing and analytical skills.

Responsibilities

• Assist in regulatory submissions and ensure compliance with regulations.
• Review product labeling and prepare documentation for registrations.

Skills

US Medical Device Regulations

EU Medical Device Regulations

ISO 13485

Technical Writing

Analytical Problem Solving

Interpersonal Communication

Regulatory Applications Submission

Familiarity with SaMD

Education

Bachelor's degree in STEM or Regulatory Affairs

Tools

Regulatory Databases

Job description

Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world. Owlet has helped more than a million parents keep their children safe, while bringing joy and sleep to the parenting journey. We believe every parent deserves the peace of mind that comes with a better understanding of their baby’s needs.

The Regulatory Specialist II will contribute to Owlet’s regulatory team by supporting product development and ensuring regulatory compliance across Owlet’s product portfolio, with a focus on wearable medical device technology and consumer electronics. Leveraging 3-5 years of relevant experience, this position will be involved in the development of submissions for domestic and international clearances and will support daily regulatory activities related to new product development, change control, and product 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 (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:

• Thorough understanding of US, EU, Canadian and/or other global Medical Device Regulations
• Thorough knowledge of ISO 13485 quality system requirements
• Experience compiling and submitting regulatory applications and submissions
• Bachelor's degree in a relevant field (e.g., STEM, Regulatory Affairs, or related) and a minimum of 3 years of experience in the medical device industry
• Familiarity with SaMD and/or wearable technology is preferred
• Other compliance experience (i.e. EU RED, CPSC, FCC, RCM) 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
• Competitive compensation based on experience

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.