Suhas Tandale

Experienced Regulatory Affairs Specialist with a strong background in developing regulatory strategies, preparing global submissions (FDA, EU MDR, MDD, MDR), and supporting Class II/III medical devices. Skilled in assessing product and process changes for regulatory implications, supporting clinical trials, and maintaining compliance with worldwide laws, guidelines, and standards. Proven ability to collaborate with cross-functional teams and communicate effectively with regulatory agencies and device reviewers. Experienced in post-market surveillance, audit readiness, and serving as a core team member in product development programs. Proficient in negotiating with the FDA and other global regulatory bodies.

• Collaborated with cross-functional teams to optimize regulatory documentation workflows, resulting in a 15% reduction in submission delays and improved operational efficiency; key metrics in financial performance.
• Led strategic planning initiatives for global market approvals, aligning regulatory timelines with business objectives to support revenue growth and financial forecasting.
• Managed tracking and control systems (SAP, ERP, Veeva Vault), enhancing data accuracy and audit readiness; critical for financial compliance and reporting.
• Contributed to cost-saving strategies by streamlining documentation processes and reducing redundancies in regulatory submissions.
• Supported budgeting efforts for regulatory projects by estimating resource requirements and aligning with financial constraints.