Quality Systems Engineer

Efficient Auditing; San Francisco (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Efficient Auditing is seeking a Regulatory Affairs Specialist to lead regulatory submissions and ensure product compliance across pharma, biotech, and medical device clients. The role requires strong documentation, regulatory strategy, and cross-functional collaboration in highly regulated environments.

The ideal candidate has 2–6 years of experience and a solid grasp of FDA/EMA pathways, eCTD formats, and global regulatory requirements.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Biotechnology, or a related field.
• 2–6 years of experience in regulatory affairs in pharma, biotech, or medical devices.
• Strong understanding of FDA, EMA, ICH, and global regulatory pathways.
• Excellent knowledge of submission formats including eCTD and technical documentation requirements.
• Strong communication, documentation, and analytical skills.
• Ability to manage multiple projects with tight timelines.

Responsibilities

• Prepare, review, and submit regulatory documents including IND, NDA, ANDA, DMF, 510(k), CE Marking files, and other global submissions.
• Ensure compliance with FDA, EMA, WHO, MHRA, and international regulatory frameworks.
• Maintain up-to-date knowledge of global regulations affecting pharmaceutical, biotech, and medical device products.
• Support clients during regulatory audits and inspections by ensuring required documentation and records are complete.
• Coordinate with R&D, Quality, Manufacturing, and Clinical teams to gather information for submissions.
• Monitor regulatory changes and communicate their impact to internal teams and clients.
• Review product labeling, marketing materials, and technical documentation for regulatory accuracy.
• Assist in lifecycle management of products, including variations, renewals, and post-approval changes.
• Support the development of regulatory strategies for new products, markets, and technology lines.

Skills

Regulatory affairs expertise

Regulatory strategy

Documentation

Communication

Project management

Education

Bachelor’s or Master’s degree in Life Sciences

Tools

eCTD publishing tools

Job description

Job Summary

We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to support regulatory submissions, product compliance, and global registration activities for pharmaceutical, biotech, medical device, and life-science clients. This role is essential for ensuring that all products, processes, and documentation meet the requirements of FDA, EMA, MHRA, and other international regulatory authorities. The ideal candidate is experienced in documentation, regulatory strategy, and cross-functional collaboration within highly regulated environments.

Key Responsibilities

• Prepare, review, and submit regulatory documents including IND, NDA, ANDA, DMF, 510(k), CE Marking files, and other global submissions.
• Ensure compliance with FDA, EMA, WHO, MHRA, and international regulatory frameworks.
• Maintain up-to-date knowledge of global regulations affecting pharmaceutical, biotech, and medical device products.
• Support clients during regulatory audits and inspections by ensuring required documentation and records are complete.
• Coordinate with R&D, Quality, Manufacturing, and Clinical teams to gather information for submissions.
• Monitor regulatory changes and communicate their impact to internal teams and clients.
• Review product labeling, marketing materials, and technical documentation for regulatory accuracy.
• Assist in lifecycle management of products, including variations, renewals, and post-approval changes.
• Support the development of regulatory strategies for new products, markets, and technology lines.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Biotechnology, or a related field.
• 2–6 years of experience in regulatory affairs in pharma, biotech, or medical devices.
• Strong understanding of FDA, EMA, ICH, and global regulatory pathways.
• Excellent knowledge of submission formats including eCTD and technical documentation requirements.
• Strong communication, documentation, and analytical skills.
• Ability to manage multiple projects with tight timelines.

Preferred Skills

• Experience with digital regulatory systems or eCTD publishing tools.
• Knowledge of GMP, GDP, and ISO 13485 regulatory interactions.
• Familiarity with clinical research submissions (CTA, IND amendments, safety reports).
• Understanding of quality systems and risk management frameworks.

Why Join Us?

• Opportunity to work on global regulatory projects across multiple industries.
• Exposure to innovative technologies and diverse regulatory frameworks.
• Professional growth in a supportive, compliance-driven environment.
• Work on high-impact projects that contribute to patient safety and public health.