We are looking for a viable candidate to fill the position of a Regulatory Affairs Coordinator in Somerset, NJ. Position Responsibilities Include:
Maintaining of Design Control project files as well as preparation and provision of input as required for regulatory and quality responsibilities
Provide assistance to QA/RA Manager in completing product submissions as required for domestic and international sales, including 510k, Canadian License submissions, Notified Body updates
Working with QA/RA Manager to maintain “Change Management” system and ensure significant changes are documented and communicated to appropriate regulatory groups
Reviewing and revising of in-house Material Safety Data Sheets (MSDS); Maintain MSDSs received from suppliers – scan, file, update Chemical Inventory List
Creating or updating of Regulatory or QS procedures to ensure regulatory compliance
Performing internal audits as a member of Internal Auditing team
May participate in Third Party audits as support to QA/RA Manager
Working with QA/RA Manager in maintaining quality systems policies and procedures to ensure Regulatory compliance by following FDA QSR, MDD, and ISO requirements
Non-Negotiable Requirements:
Min. Bachelor’s degree (sciences or in engineering preferred) or 5 years relevant work experience in ISO13485 or ISO9001 regulated establishment
Familiarity with interpreting regulations and quality systems.
Working knowledge of FDA QSR, ISO13485 or ISO9001 standards preferred, but not required
Exceptional organizational skills
Excellent writing skills
Good interpersonal and communication skills
Ability to work independently
Able to effectively manage time to meet assigned deadlines and prioritize multiple work assignments.
WORD, EXCEL, ACCESS, OUTLOOK
Hours: 40 hrs/week Pay: $20-$25/hour (BOE)
To apply for this position, email: job@completepersonnel.com Attach Resume, Salary Requirments and relevent work experience.