Job Title [Quality Regulatory Administrator]
Job Title: Quality/Regulatory Administrator
Reports to: VP Quality Regulatory
Position Type: Full Time- Exempt
The Quality Regulatory Administrator will provide support to Katena’s global distributor network and the QA/RA team
- Support global distribution network by resourcing and providing QA/RA documentation & records as required for in-country regulatory registrations, listings and licensing of Katena distributed medical devices.
- Support international product distribution by resourcing and providing product specific QA certificates, as needed for various shipments.
- Support QA/RA team in the maintenance of various QA/RA databases used to support product line registrations, certifications, licensing/listings, and distribution controls.
- Support QA/RA team in compliation of data, generate various quality system / regulatory reports, presentations as needed for global regulatory needs.
- Support QA/RA team in the ongoing supplier / distributor assessment, agreements and monitoring program.
- Support QA/RA team with ongoing Quality Management System document / change control.
- Monitor, research and resource various forms of product feed-back for Post-Market Surveillance purposes.
- Support QA/RA team during quality system audits and 3rd party inspections.
- Assist QA/RA team by maintaining various QA/RA Quality System files such as distributor regulatory files, product registrations / agreements and assessment files.
- Support QA/RA Team in the maintenance of UDI program, internal and 3rd party product barcode databases.
Expertise: Knowledge & Skills
- Detailed Oriented / Energenic /Self Motivated / Career Oriented person with exceptional organizational skills
- Some working knowledge of Medical Device compliance (FDA 21 CFR 820) & ISO 13485.
- Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative, distributors & management personnel
- Proficient in Microsoft Office applications (advanced Excel, Word, PowerPoint)
- Strong verbal and written Communication Skills
Required Education and Experience
- Associate degree (AA) or equivalent from a two-year college or technical school, or six months to one year related experience and/or training, or equivalent combination of education and experience.
- Some College preferred or 2-5 years’ experience in Med Device or QA/RA
- Must be able to drive, own a car and be willing to drive to county courthouse for notary certifications.
- Morris County Notary a plus
- Backup/ team coverage of other functions such as:
- Assistance with incoming product release activities
- Assistance in reporting activities
- Assistance in Power Point presentation development
- Administrative support for Quality/Regulatory Team
- Other projects and duties as assigned by to other departments with manager’s approval