Regulatory Affairs Specialist (FDA, DEA )
$60K - $76K/yr
Knowledge of NABP license portals, MedWatch reporting, or REMS programs * Regulatory Affairs ... FULL_TIME
Regulatory Affairs Specialist (FDA, DEA )
$60K - $76K/yr
Knowledge of NABP license portals, MedWatch reporting, or REMS programs * Regulatory Affairs ... FULL_TIME
Lancaster General Health in Lancaster, PA SCHEDULE: Full time (36 hours per week), Monday - Friday ... Responsible for reporting any MR safety accidents directly to the FDA via Medwatch * Assist the MR ...
Lancaster General Health in Lancaster, PA SCHEDULE: Full time (36 hours per week), Monday - Friday ... Responsible for reporting any MR safety accidents directly to the FDA via Medwatch * Assist the MR ...
Lead the quality review and timely submission of all OTC drug and cosmetic MedWatch reports to the ... Authorization to work in the United States on a full-time, permanent, ongoing basis without the ...
Lead the quality review and timely submission of all OTC drug and cosmetic MedWatch reports to the ... Authorization to work in the United States on a full-time, permanent, ongoing basis without the ...
Full Time Medwatch information
What is the difference between Full Time Medwatch vs Part Time Medwatch?
| Aspect | Full Time Medwatch | Part Time Medwatch |
|---|---|---|
| Work Hours | Typically 35-40 hours per week | Less than 20 hours per week |
| Certifications | Required certifications usually include medical device monitoring and compliance training | Same certifications as full-time, but may vary based on hours |
| Work Environment | Office or hospital settings, monitoring medical device safety | Similar environments, often with flexible scheduling |
| Employer Usage | Hospitals, medical device companies, regulatory agencies | Same as full-time, with more flexible roles |
Full Time Medwatch roles involve standard 35-40 hour workweeks with comprehensive responsibilities in medical device safety monitoring. Part Time Medwatch offers flexible hours but requires similar certifications and work environments. The choice depends on your availability and career goals within the medical device industry.
More about Full Time Medwatch jobs
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What job categories do people searching Full Time Medwatch jobs look for? The top searched job categories for Full Time Medwatch jobs are:
$60K - $76K/yr
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 29 days ago
Job description
Job Summary
The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of evolving federal and state regulations related to pharmaceuticals, medical devices, and controlled substances.
Key Responsibilities- Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates)
- Oversee and renew DEA registrations, inventory records, and security documentation
- Maintain state pharmacy, medical device, and wholesale distribution licenses
- Track regulatory changes affecting compounding, controlled substances, and labeling requirements
- Support internal audits, site inspections, and responses to 483s or warning letters
- Coordinate with Quality Assurance on SOP compliance, change controls, and deviation reports
- Serve as point of contact with federal and state regulatory agencies
- Document and file compliance records and ensure timely reporting
- Associate degree in Life Sciences, Regulatory Affairs, or related field (Bachelor's preferred)
- 2-4 years of regulatory or compliance experience in pharmaceuticals, biotech, or medical devices
- Working knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and DEA requirements
- Strong writing, documentation, and organizational skills
- Familiarity with electronic submission systems, labeling requirements, and drug master files
- Experience in sterile or non-sterile compounding (503A or 503B environments)
- Knowledge of NABP license portals, MedWatch reporting, or REMS programs
- Regulatory Affairs Certification (RAC) or DEA compliance training (preferred)
- Experience responding to FDA inspections, audits, or state pharmacy board requests
- Health, dental, and vision insurance
- 401(k) with employer match
- Paid time off and holidays
- Regulatory training and continuing education support
- Advancement opportunities into QA/RA leadership roles