Regulatory Affairs Specialist - Hybrid

Join a small, but growing global Medical Device company. Innovators using cutting edge technologies for treatment of various diseases.

Benefit
Dental insurance
Flexible spending account
Health/Vision insurance
Health savings account
Life insurance
Paid time off / Holiday
401k and match

Must be legally authorized to work in the U.S. without sponsorship.
Must be willing to relocate to CA or commute for hybrid schedule

This position is responsible for documentation for submission to various regulatory agencies - most notably those pertaining to the European Medical Device Regulation. Additionally the position will help maintain and improve upon international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.

Duties and Responsibilities:
This list is not comprehensive but meant to represent the most common or important duties of the position.

• Assist with the preparation and submission of regulatory filings, including European Medical Device Regulation compliant Technical Files.
• Create and/or modify regulatory documents and procedures to remain in compliance with European, ISO, FDA, ISO, Canadian, and other standards.
• Work with the international department on various regulatory filings for product registration in different countries.
• Provides regulatory support for other projects as required.
• Updating appropriate personnel on new and revised processes and procedures.
• Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.

Must have:

• Bachelor’s Degree
• 510k, IDE, PMA Submissions (At least 5 years)
• Regulatory Affairs experience within Medical Device

Nice to have:

• Knowledge of European, ISO 13485 and ISO 14971 FDA regulations preferred.
• Knowledge of international regulatory guidelines regarding EU regulations