Regulatory Affairs Specialist II

Quality, regulatory and pharmacovigilance groups work across every site. Granitekeep Therapeutics is a global biopharmaceutical company with medicines approved in more than 60 countries.

ROLE OVERVIEW:

The Regulatory Affairs Specialist II works with R&D, quality and clinical to build regulatory strategy and keep products compliant after launch. Hybrid, with three days a week in our Los Angeles office.

YOUR RESPONSIBILITIES:

• Coordinate with international distributors on country registrations
• Support EU MDR technical documentation and notified body reviews
• Maintain establishment registrations and device listings
• Monitor new guidance documents and summarize changes for the business
• Respond to FDA information requests and deficiency letters with the project team
• Keep regulatory files and correspondence organized and inspection ready

QUALIFICATIONS:

• 3-5 years of regulatory affairs experience in medical devices, pharma or biologics
• Familiarity with eCTD structure and submission publishing tools
• Bachelor's degree in a life science, engineering or pharmacy
• Hands-on experience preparing at least one FDA submission
• Comfortable managing several submissions and deadlines at once
• Clear technical writing and careful editing
• Knowledge of ISO 13485 and ISO 14971 for device roles

PREFERRED QUALIFICATIONS:

• Experience with Veeva Vault RIM
• RAC certification from RAPS
• Software as a medical device (SaMD) and cybersecurity submissions

Compensation: $113,000 - $146,000 per year DOE.

BENEFITS:

• Health savings account (HSA) with employer contribution
• 401(k) with company match
• Three weeks of PTO to start
• Sign-on bonus
• Professional development budget
• Flexible schedule

Granitekeep Therapeutics provides equal employment opportunities to all employees and applicants.

Start: Within 30 days.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Granitekeep Therapeutics.