Regulatory Assistant

Regulatory Assistant

Location: Burlingame, California (Onsite)

Role Overview

The Regulatory Affairs Associate is a vital member of the regulatory affairs team, working primarily with wearable devices and digital health solutions. This role will support the development and execution of regulatory strategy and will also contribute to developing a regulatory intelligence platform for the organization. The associate will help design and implement best practices in a fast-paced and growing regulatory team.

Key Responsibilities

• Work with management to execute and document regulatory strategy by supporting the planning, preparation, and delivery of regulatory submissions.
• Develop detailed project plans and support regulatory activities for specific product portfolios.
• Participate as an active team member and provide regulatory advice to project teams as required.
• Coordinate responses to Health Authority (HA) questions with strict deadlines.
• Maintain regulatory files in a format consistent with internal requirements.
• Facilitate the review of technical regulatory documentation and recommend changes for regulatory compliance.
• Demonstrate organizational and project management skills to prioritize multiple projects.

Required Qualifications

• B.S. or higher in engineering or a related discipline.
• 2+ years of experience in a regulatory role in a medical device company.
• Experience working on documentation and submissions to the FDA and global Health Authorities.
• Experience working with medical devices is preferred.
• Exceptional communication skills, including writing test plans, summarizing evaluation processes, and preparing reports.
• Must be a self-starter and motivated individual who works well across multiple teams.

Preferred Qualifications

• Experience working with wearables, hearables, or fitness brands.
• A personal connection to improving hearing health.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at

Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

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