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Regulatory - Medical Device- Pharma

Location:Miami, FL, United States (Anywhere)

Education level: Masters
Education field: Biological and Biomedical Sciences
Years of experience: more than 5
Attributes that best describes:
Team player
Entrepreneur
Planner
Logical
Creative

Skills:
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by over 9 years of experience in the field, including 6 years working at the US Food and Drug Administration (FDA - ORA and CDRH), and a solid educational background with a Master’s of Science (MS) in Biomedical Engineering, MS in Pharmacy, Regulatory Affairs Certificate, and a Regulatory Affairs Certification (RAC Global). Driven by a keen interest in the field, developed expertise in and acquired substantial knowledge on the US, EU, and global regulations of medical devices, pharmaceutical products, and combination products.

The services I can assist with include:

PRE-MARKET RELATED
- Product idea/concept brainstorming - (to) - Product development - (to) - Regulatory strategy planning - (to) - Pre-market application preparation and submission - (to) - market authorization - (to) - commercialization - (to) - Post-market total product lifecycle management
- Technology/Product approvability evaluation for technical and regulatory due diligence including regulatory requirement review (product classification, guidance documents, applicable international standards, guidelines, etc…)
- Design control activities (i.e. 21 CFR 820.30) - Product risk management (i.e. ISO 14971) - Usability / Human Factors studies
- Application types : 510(k), PMA, HDE, IDE, NDA, ANDA, 505(b)(2), IND etc…
- Correspondence with regulatory agencies (pre-submission meetings, response letters, information requests, etc…)

POST-MARKET RELATED
- Quality system development, improvement, management, record keeping and maintenance, gap analysis (including drafting and reviewing records, work instructions (WI), standard operating procedures (SOPs), and other quality system related documents)
- Facility audits (mock FDA/MDSAP inspections) against US 21 CFR 820 (Medical Devices), 21 CFR Part 4 (Combination Products), ISO 13485
- Manufacturing / Production and Process Controls: Design transfers to production, manufacturing line qualification, process validation, etc…
- Complaint handling including recall initiation and processing, and adverse event reporting (i.e. MDR, AER)
- Compliance related correspondence with authorities (deficiency remediation updates, FDA Form 483 Observations, Warning Letters, Untitled Letters, Recalls 806 Reports, MDR 803 Reports, Regulatory Meetings, Injunctions, Seizures, Civil Money Penalties, etc...)

GENERAL REGULATORY AFFAIRS
- Regulatory project management
- Regulatory/Compliance strategy development
- Workshops and training / Startup coaching
- US FDA Imports requirements

 
 
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