Regulatory Compliance Consultant

Efficient Auditing; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Opportunity to work with global clients

Exposure to diverse compliance challenges

Supportive work environment

Job summary

A leading consulting firm is seeking a highly skilled Regulatory Compliance Consultant to support clients in pharmaceutical, medical device, biotech, and life-science sectors. Candidates should have a Bachelor’s or Master’s degree, with 3–5 years of experience in regulatory affairs. Responsibilities include conducting compliance assessments, assisting in QMS development, and providing regulatory guidance. Join a supportive environment that offers diverse challenges and continuous learning opportunities.

Qualifications

• 3–5 years of experience in regulatory affairs, compliance, or quality management in a regulated industry.
• Experience conducting audits and managing corrective and preventive actions.
• Ability to manage multiple client projects with strong attention to detail.

Responsibilities

• Conduct regulatory compliance gap assessments for clients in pharma and medical devices.
• Assist in developing Quality Management Systems aligned with ISO standards.
• Support clients during regulatory inspections by providing documentation support.

Skills

Regulatory compliance knowledge

Analytical skills

Excellent documentation

Communication skills

Education

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Engineering

Job description

We are seeking a highly skilled Regulatory Compliance Consultant to support clients across pharmaceutical, medical device, biotech, and life‑science sectors. The ideal candidate will guide organizations in achieving and maintaining compliance with global regulatory standards, including FDA, EMA, ICH, WHO, ISO, and GMP guidelines. This role involves performing compliance assessments, supporting audits, preparing documentation, and helping clients strengthen their quality and regulatory systems.

Key Responsibilities

• Conduct regulatory compliance gap assessments for clients in pharma, medical devices, and life sciences.
• Assist in the development, implementation, and improvement of Quality Management Systems aligned with ISO 9001, ISO 13485, GMP, GDP, and GLP requirements.
• Prepare, review, and maintain regulatory documentation, SOP(';SOPs');'SOPs, validation protocols, risk assessments, and quality reports.
• Support clients during regulatory inspections (FDA, EMA, MHRA, WHO) by providing readiness assessments, documentation support, and audit coaching.
• Lead internal and external audits, document findings, and track corrective and preventive actions (CAPA) to closure.
• Provide regulatory guidance on product registration, market approvals, quality controls, and compliance strategies.
• Develop and deliver compliance training programs tailored to client requirements.
• Collaborate with cross‑functional client teams to ensure processes and systems remain compliant and inspection‑ready.
• Prepare regulatory submissions and ensure timely responses to audit observations or inspectional findings.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field.
• 3–5 years of experience in regulatory affairs, compliance, or quality management in a regulated industry.
• Strong knowledge of FDA, EMA, ICH guidelines stockage; volume; storage; stress; packaging; manufacture' etcbut what you want.
• Experience conducting audits and managing CAPO processes.
• Excellent documentation, analytical, and communication skills.
• Ability to manage multiple client projects with strong attention to detail.

Preferred Skills

• Experience working with consulting firms or as a regulatory advisor.
• Certifications such as CQA (Certified Quality Auditor), RAC (Regulatory Affairs Certification), or ISO Lead Auditor.
• Understanding of risk management tools such as FMEA, HACCP, or ISO 14971.
• Familiarity with electronic QMS or validation software.

Why Join Us?

• Opportunity to work with global clients across multiple regulated industries.
• Exposure to diverse compliance challenges and continuous learning opportunities.
• Supportive work environment with growth‑focused leadership.