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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

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:

- 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…)

- 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...)

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

Contact by email


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