Regulatory Device Specialist

📋 Description

• Prepare pre-market submission reports / technical files per the requirements of key regulatory
• Review, interpret, and communicate FDA/international regulations and guidance documents to ensure
• Perform regulatory review of post-market product changes and decide on appropriate mechanism for
• Assist in the update, enhancement, and creation of internal policies and procedures.
• Support regulatory compliance to QSR, ISO, FDA, and other worldwide regulatory requirements as
• Compile, submit, and manage international product registrations, license renewals, and registration

🎯 Requirements

• Minimum of 3 years Medical Device Regulatory Experience required; aesthetics experience preferred.
• Solid understanding of cGMP for Medical Devices, ISO 13485, FDA and EU MDR requirements.
• Demonstrated experience obtaining and maintaining medical device registrations in at least three
• Hands-on experience authoring or compiling regulatory dossiers in multiple formats, including FDA
• Working knowledge of MDSAP, UKCA, and Notified Body review processes, and of country-specific
• Ability to manage multiple concurrent international submissions across time zones.

🎁 Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance