Regulatory Affairs Specialist

The Regulatory Affairs Specialist performs duties associated with the channel of information and creation/filing of regulatory documents required by GCA companies, divisions, departments (GCA, GCOA, GCMA) to support company operations both domestic and globally to maximize revenue and profit.

Essential Duties & Responsibilities:

• Monitor regulatory environment in assigned markets(US, Canada) and communicate to global and domestic stakeholders
• Prepare, compile and maintain pre-market documentation required by FDA, EPA, MDSAP, ISO 13485 and Health Canada including product registrations, technical files, letters to file
• Work with product management to prepare, compile and maintain post market documentation
• Prepare responses to regulatory authority requests by working with GCC regulatory affairs
• Consult with Product Management and Sales Administration on regulatory requirements for US and Canada
• Work with other GC Companies regulatory associates to support GCA sales and marketing needs associated with regulatory documentation
• Pay invoices to maintain regulatory body registrations
• Uphold the principles and practices of the GQM business management system, including QC Thinking, Kaizen Innovation, and the corporate philosophy of GC no Kokoro.
• Participate in regulatory compliance activities related to the job function, including quality audits, adverse event reporting for company products, and adherence to Good Documentation Practices for reporting and record keeping.
• Perform other duties as may be assigned.

Minimum Qualifications:

• Bachelor's Degree
• 3 years of experience in regulatory affairs or quality assurance
• Microsoft Office suites, SAP, Master Control
• 3 years in medical device or pharmaceutical-related regulatory affairs including FDA documents, ISO documents and standards, and electronic filing when and where applicable

Technology/Equipment

• Microsoft Office Suites, electronic document signing and transfer of sensitive documents

Benefits:

• 401(k) through Fidelity and company matching 10%
• Dental insurance with Delta Dental PPO
• Health insurance BCBS Illinois PPO
• Employee assistance program
• Health savings account
• Company Paid Life Insurance two times the annual salary
• Paid time off including an extra paid week off the week between Christmas and New Year
• Tuition reimbursement
• Vision insurance EyeMed

Job Type: Full-time

Pay: $41,829.61 - $91,062.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Alsip, IL 60803: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: Hybrid remote in Alsip, IL 60803

Salary : $41,830 - $91,062