Suhas Tandale
Actively Seeking full-time roles in Regulatory Affairs, Quality Assurance, or Compliance to apply my expertise in global regulatory frameworks, quality systems, and strategic compliance.
- Role
- Regulatory Intern at Ametek Reichert
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Suhas Tandale
Regulatory Affairs and Quality Engineering professional with hands-on experience…
Experience
Regulatory Intern
Jul 2025 — Present · Depew, NY, US
Supported the Neurovascular and ophthalmic product portfolio by assessing design, labeling, and manufacturing changes for regulatory compliance across U.S, EU, and Canada• Prepared and submitted regulatory filings (510(k), EU MDR Technical Documentation, Health Canada, China NMPA), ensuring alignment with evolving regulatory standards• Conducted regulatory environment assessments to anticipate potential submission obstacles and proposed proactive filing strategies• Reviewed and approved design control documentation, labeling, promotional materials, and engineering changes to ensure compliance throughout the product lifecycle• Compiled and maintained Technical Files, Design Dossiers, and GSPR Checklists per ISO 13485, ISO 14971, IEC 62304, and MDSAP standards• Partnered with R&D, QA, and Marketing to advise on regulatory pathways for product modifications and market access• Executed a global recall strategy (U.S, EU, Canada, LATAM, UK, Middle East) ensuring rapid alignment with regulatory requirements• Monitored post-market compliance, including vigilance submissions, MDR reporting, CAPA documentation• Participated in FDA pre-submission activities, compiling substantial evidence for timely approvals• Engaged in MDSAP audit readiness, conducting gap assessments and remediation planning to maintain inspection readiness
Education
Northeastern University
Masters of Science, Regulatory affairs
DY Patil University
Bachelor of Pharmacy - BPharm, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2019 — 2023
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