Global Regulatory Affairs Expert – Pharma & MedTech

Efficient Auditing; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Flexible working culture

Job summary

Efficient Auditing in Austin, TX seeks a detail-oriented Regulatory Affairs Specialist to support clients in meeting global regulatory requirements for pharmaceuticals, medical devices, and biotechnology.

You will prepare, review, and manage submissions (IND, NDA, 510(k), CE Marking), drive regulatory strategy, ensure audit-ready documentation, and stay current with FDA, ICH, and ISO guidelines. Collaborate with QA, manufacturing, and R&D to maintain compliance throughout product lifecycles.

Qualifications

• 2–5 years hands-on regulatory experience in pharma, medical devices, or biotech.
• Strong understanding of FDA regulations, ICH guidelines, EU MDR/IVDR.
• Experience preparing or reviewing regulatory submissions and technical documents.

Responsibilities

• Prepare, review, and manage regulatory submissions (IND, NDA, ANDA, 510(k), CE Marking documentation).
• Support regulatory strategy development for product registration and approval.
• Ensure all regulatory documents are complete, accurate, and audit-ready.
• Maintain up-to-date knowledge of global regulatory requirements and changes.
• Coordinate communications with regulatory agencies and assist in responding to queries.

Skills

Regulatory submissions

Technical documentation

Lifecycle management

FDA regulations

ICH guidelines

Education

Bachelor's or Master in Regulatory Affairs or Life Sciences

Tools

eCTD submissions

Document management systems

Job description

Efficient Auditing in Austin, TX seeks a detail-oriented Regulatory Affairs Specialist to support clients in meeting global regulatory requirements for pharmaceuticals, medical devices, and biotechnology.

You will prepare, review, and manage submissions (IND, NDA, 510(k), CE Marking), drive regulatory strategy, ensure audit-ready documentation, and stay current with FDA, ICH, and ISO guidelines. Collaborate with QA, manufacturing, and R&D to maintain compliance throughout product lifecycles.