Regulatory Affairs Manager jobs in Suffolk, VA

Regulatory Specialist

Do you have a passion for research and providing exceptional customer service? Are you able to multitask and have strong problem-solving skills? Apply today to our Regulatory Specialist position with Registrar Corp! Registrar Corp is looking for a Regulatory Specialist that will work with our Medical Device team to research FDA issued guidelines and federal regulations relating to medical devices to help our clients be compliant with those guidelines.

Role information:

• Manage and respond to customer, regulatory agency, and/or distributor requests for quality, regulatory, or technical information
• Perform administrative work, to include data entry, PDF editing, editing of XML files, and electronic document preparation and submission
• Draft client reports that explain the regulations that govern products under review and identify any potential compliance issues
• Conduct regulatory research related to FDA-regulated medical devices
• Communicate directly with clients, including foreign manufacturers who export to the USA and wish to ensure that their medical devices are compliant with current FDA regulations
• Prepare, verify, and/or maintain technical files pertaining to submissions or other FDA-required activities throughout the product lifecycle, gaining an understanding of the regulatory implications of the product profile.

Skills:

• Ability to analyze various medical device submissions and properly interpret and report results
• A passion for managing information and improving processes/programs
• Excellent written, verbal, and non-verbal communication skills
• Ability to stay organized and handle multiple projects at once
• Strong technical and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.)
• A natural talent for problem-solving and critical thinking, with the willingness to learn and improve

Requirements:

• Bachelor’s degree or higher preferred, ideally in a scientific discipline or other writing and research-intensive field of study or equivalent experience
• 1-2 years of experience in a research or compliance related field is preferred, but not a requirement. Comprehensive training will be provided!
• Foreign language skills (particularly Spanish) a plus
• Ability to work onsite for 2 week traning period in Hampton, VA, hybrid/remote flexibility after successful training period
• Work Monday through Friday, 10am – 6pm

Perks and Benefits:

• Paid time-off and paid vacation time
• Medical, Dental, Vision, 401(k) with company match
• Fun, collaborative work environment
• Hybrid/Remote flexibility

Compensation target $17-18/hour

About Registrar Corp:

Registrar Corp is a private consulting firm that helps companies comply with U.S. Food and Drug Administration regulations. Registrar Corp is based in Hampton, Virginia, and has 18 offices around the world, with clients in over 160 countries. Registrar Corp is not affiliated with the U.S. FDA.