US FDA Regulatory Affairs Expert

Job highlights

• Strong knowledge of US FDA Regulatory Affairs with practical experience in FDA submissions and regulatory consulting
• Conduct US FDA regulatory training programs, develop training materials, deliver sessions on medical devices, pharmaceuticals, food & cosmetics regulations, and assess participants

Responsibilities

• Conduct US FDA regulatory training programs for industry professionals and students.

•Develop comprehensive training modules, presentations, case studies, and learning materials.

•Deliver training on various US FDA regulatory pathways, including

Medical Devices

•US FDA Medical Device Classification (Class I, II, III)

•510(k) Premarket Notification

•De Novo Classification

•PMA (Premarket Approval)

•FDA Establishment Registration &

• Device Listing

•Quality Management System (21 CFR Part 820 / QMSR)

•Design Controls &

• Risk Management

•UDI Requirements

•Medical Device Reporting (MDR)

Pharmaceuticals

•US FDA Drug Development Process

•IND &

• NDA Applications

•ANDA Submissions

•DMF Requirements

•cGMP Requirements

•Regulatory Compliance &

• Inspections

Food &

• Cosmetics

•FDA Facility Registration

•Food Facility Registration (FFR)

•FSVP Requirements

• R RAS &
• Food Additives

•Cosmetic Facility Registration &

• Product Listing (MoCRA)

•Labeling Requirements

•Explain regulatory concepts with practical examples and industry case studies.

•Conduct webinars, workshops, and corporate training sessions.

•Assess participants through quizzes, assignments, and practical exercises.

•Support ELT in developing professional regulatory training courses.

•Keep training content updated with latest FDA regulatory changes.

Required Skills &

• Experience

•Strong knowledge of US FDA Regulatory Affairs and compliance requirements.

•Practical experience in US FDA submissions and regulatory consulting.

•Experience in conducting regulatory training programs preferred.

•Ability to simplify complex regulatory requirements for learners.

•Excellent presentation, communication, and interpersonal skills.

Preferred Regulatory Expertise

Candidates having experience in one or more areas

-US FDA Medical Device Registration

-510(k), De Novo, PMA Submissions

-FDA QMSR / 21 CFR Part 820

-FDA Drug Approval Process

-ANDA / NDA / IND Submissions

-FDA Food Facility Registration &

• Compliance

-FSVP Regulations

-FDA Cosmetic Regulations (MoCRA)

-FDA Regulatory Audits &

• Inspections R