Robert Michalik
FDA Quality, Clinical & Regulatory compliance, development and submissions SME
- Role
- Senior Consultant, Fda Quality, Clinical & Regulatory Compliance at Bioboston Consulting
- Location
- North Conway, NH, US
- LinkedIn followers
- 500 followers
About Robert Michalik
As an experienced protein biochemist and Regulatory Affairs professional with over 25 years experience in the biopharma and medical device industries, I offer an array of regulatory, clinical, quality and legal services to FDA-regulated client companies.Particular expertise in the following areas- U.S. and international regulatory strategy design-\"hands on\" clinical research and operations support- Regulatory applications drafting and submission services, including.* Investigational exemptions (INDs and IDEs) and Product Registration applications (BLA, NDA).* Medical device \"510(k)\" applications, EU MDR registrations and \"Regulatory Letters-to-File\".* Quality System development, Gap analysis/remediation and auditing(FDA 21 CFR & ISO 13485)
Experience
Senior Consultant, Fda Quality, Clinical & Regulatory Compliance
Sep 2025 — Present · Boston, MA, US
Assist BioBoston clients with a range of pre- and post-market strategic planning, development and regulatory submission services in FDA regulated industries (Pharma, Biologics & Medical Devices).Expertise focused in areas of premarket development, and AI-enhanced products and development processes.
Education
University of Massachusetts Amherst
B.S., Biochemisty
Suffolk University Law School
J.D., Law
Skills
- Pharmaceutics
- Clinical Trials
- Regulatory Filings
- U.s. Food and Drug Administration (Fda)
- Medical Devices
- Clinical Research
- Capa
- R&D
- Biopharmaceuticals
- Clinical Development
- Regulatory Submissions
- Ind
- Life Sciences
- Iso 13485
- Regulatory Affairs
- Lifesciences
- 510 K
- Pharmaceutical Industry
- Fda
- Technology Transfer
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