Support the preparation of US and International regulatory filings and registrations. Ensure compliance with US and international regulations, standards and guidance.
Great opportunity to learn and grow in the field of medical device regulatory affairs. Ideal position for a recent Regulatory Affairs graduate, someone with 1 to 3 years of hands-on regulatory experience, or someone looking to transition to Regulatory Affairs from a complementary function such as Quality Assurance.
Key responsibilities include the following:
Support international device licensing and registrations
Support regulatory product submissions
Support the creation and maintenance of Device Master Records and Technical Files
Support regulatory strategy development for new product introductions into domestic and international markets
Support and participate in internal and external Quality System Audits
Author technical writing
Organized and detail orientated. Proficient in Microsoft Word, Excel, Access. Good oral and written communication skills. Ability to adjust to changing priorities. Strong analytical and problem solving skills.
Maintain regulatory affairs product files to support compliance with requirements and standards. Maintain the company’s Medical Device Listing and Device Establishment registration forms. Prepare and update Technical Files. Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
Knowledgeable in 21 CFR Part 820, 21 CFR Part 11, ISO 13485, CMDCAS, and European Medical Device Directives.
Experience in medical device or pharmaceutical industry preferred; however, recent graduates are encouraged to apply as well
RAC or ASQ certification is a plus
Bachelor’s degree. Scientific discipline, preferred but required
Internal Number: 1
About Parker Laboratories
Parker Laboratories is a leading global medical products company that develops, manufactures and sells ultrasound and electromedical contact media, as well as leading lines of institutional cleaners and disinfectants. We are focused on consistently providing products that meet or exceed industry standards and customer expectations. We create customer confidence through prompt, efficient service and provide effective solutions to our customers' unique needs.