Regulatory Compliance Associate - Quality & Documentation

Paycom; Williams (OR); On-site; USD 50,000 - 56,000; Full time

Job summary

Herb Pharm is seeking an Associate Regulatory Compliance Specialist to support the Quality department in maintaining regulatory compliance programs, document control systems, and customer complaint processes. The role requires attention to detail, organization, and a desire to build a career in regulatory affairs and quality compliance.

The candidate will oversee the product complaint system, assist with regulatory documentation including MedWatch filings, and coordinate document control

Qualifications

• Bachelor’s degree in related field.
• Associate degree with relevant internship or work experience may be considered.
• Minimum 2 years of experience or training in quality management systems or laboratory setting as it pertains to consumer product goods.
• Experience with document control systems in a regulated industry preferred.
• Equivalent combination of education and experience will be considered.

Responsibilities

• Oversee and implement the product complaint system including packaging and herbal complaints, adverse events, and serious adverse events.
• Ensure regulatory compliance with the complaint system including accurate documentation of complaint status, investigations under the direction of the Quality management team. Assist with the preparation of regulatory documentation, including the filing of MedWatch documentation for serious adverse events.
• Prepare and organize structure function documentation for review and submission to FDA portal.
• Support maintenance of distributor compliance portals including submission of required documentation, resolution of action items, and necessary follow-up to support the Sales department goals.
• Assist with regulatory audits and inspections by gathering requested documentation.

Skills

Regulatory compliance

Document control

Quality systems

Regulatory audits

Education

Bachelor’s degree in related field

Associate degree with relevant internship or work experience

Tools

MS Office Suites

Job description

Herb Pharm is seeking an Associate Regulatory Compliance Specialist to support the Quality department in maintaining regulatory compliance programs, document control systems, and customer complaint processes. The role requires attention to detail, organization, and a desire to build a career in regulatory affairs and quality compliance.

The candidate will oversee the product complaint system, assist with regulatory documentation including MedWatch filings, and coordinate document control