Regulatory Affairs Specialist II

Regulatory Affairs Specialist IILocation: Remote (Must Live in West Coast and be able to work: 8:00 AM–5:00 PM PT or 9:00 AM–6:00 PM PT)Duration: 12-Month Contract with Potential ExtensionPay: $42 an hour or about $84,000 a yearWork Authorization: Applicants must be authorized to work in the United States without current or future visa sponsorship.Position OverviewWe are seeking a Regulatory Affairs Specialist II to support regulatory submissions, compliance activities, and product development initiatives within a medical device environment. This role offers a unique opportunity to join an experienced Regulatory Affairs team while gaining exposure to regulatory strategy, submission management, and compliance activities throughout the product lifecycle.The position will begin with a structured training program focused on internal systems, processes, and procedures. Following training, the primary responsibility will be managing and archiving regulatory submissions to help reduce an existing backlog. As proficiency is demonstrated, the individual will gradually transition into broader Regulatory Affairs responsibilities, including submission preparation, regulatory strategy support, and cross-functional project participation.The selected candidate will join a team of approximately 12 Regulatory Affairs professionals and work closely with a smaller group of 2–3 Regulatory Specialists.Important: Candidates whose primary background is Medical Writing will not be considered for this position.Key ResponsibilitiesSupport regulatory submissions and ongoing regulatory compliance activities for medical device products.Assist in the development and implementation of regulatory strategies for new and modified products.Prepare, review, and maintain regulatory submissions and supporting documentation.Serve as a Regulatory Affairs representative on cross-functional product development teams.Collaborate with regulatory agencies and reviewers through written and verbal communications regarding submission strategies, testing requirements, and ongoing reviews.Review product labeling, promotional materials, and advertising content for regulatory compliance.Evaluate and approve product and manufacturing changes to ensure compliance with applicable regulations.Maintain accurate regulatory records and documentation within regulatory management systems.Support submission archiving activities and document management processes.Quality System ResponsibilitiesDemonstrate a strong commitment to patient safety, product quality, and compliance with all applicable quality system requirements.Follow established quality procedures, policies, and documentation requirements.Contribute to a culture of continuous compliance and quality improvement.Required QualificationsBachelor’s degree with 2–4 years of Regulatory Affairs experience, ORMaster’s degree with 0–2 years of Regulatory Affairs experience.Demonstrated experience working in Regulatory Affairs within a regulated industry, preferably medical devices.Experience using regulatory management systems for submission management, document control, and archiving activities.Strong proficiency with Microsoft Office applications.Excellent written and verbal communication skills.Ability to work independently with minimal supervision while effectively collaborating across multiple departments.Strong organizational skills and attention to detail.Dedicated home office environment with reliable internet connectivity.Preferred QualificationsMaster’s degree in Regulatory Affairs.Experience using Windchill.Experience supporting medical device regulatory submissions and product development activities.Familiarity with FDA and international regulatory requirements.Ideal Candidate ProfileThe ideal candidate is a Regulatory Affairs professional with hands-on experience managing submissions, maintaining regulatory documentation, and supporting compliance activities in a medical device environment. Success in this role requires strong organizational skills, attention to detail, the ability to work independently, and experience working within regulatory management systems. Candidates who enjoy both document management and broader regulatory responsibilities will have an opportunity to grow into a more strategic Regulatory Affairs role over time.