Akshay Satpute

Regulatory Affairs Professional with 4+ years of experience in medical devices, IVDs, and SaMD, supporting Class II & III products. Hands-on with FDA 510(k), EU MDR/IVDR, CE Marking, and global post-approval changes. Proven track record in leading cross-functional initiatives, ensuring compliance, and driving product lifecycle activities across US, EU, LATAM, and APAC markets.

Regulatory Affairs Specialist II at Bio-Rad (2025-09 – Present)

• Led coordination of post-approval regulatory activities for manufacturing site transfers, supporting FDA 510(k) and technical file updates.
• Managed 10+ international registration variations, aligning labeling and COO to ensure on-time global product clearance.
• Updated EU IVDR Technical Files for manufacturing site changes, revising Annex II & III documentation, GSPR matrices, and supporting quality/manufacturing evidence.
• Authored and maintained DMFs, coordinating with Authorized Representatives and local regulatory teams across multiple regions.
• Managed notarization, apostille, and legalization of regulatory documents for APAC/LATAM submissions, ensuring timely acceptance and compliance across multiple regions.

Regulatory Affairs Specialist II at Abbott (2025-02 – 2025-08)

Contract

• Drafted regulatory memos and partnership agreements, assessing the regulatory impact on data-sharing initiatives for SaMD products.
• Led cross-functional regulatory partnership projects, collaborating with stakeholders across R&D, QA, and legal teams to ensure SaMD compliance with FDA requirements and alignment with FDA 510(k) regulatory pathways.
• Owned preparation and regulatory review of SaMD technical documentation, including risk management files, labeling, and submission readiness assessments aligned with FDA 510(k) expectations.
• Designed and implemented regulatory tracking tools (SharePoint dashboards, Excel trackers, executive-level PPTs) to improve cross-functional visibility, decision-making, and milestone tracking for regulatory activities.

Regulatory Affairs Specialist at Philips (2024-06 – 2024-12)

Contract

• Coordinated regulatory compliance activities for Class II Ultrasound devices across global markets, supporting 8+ submissions and approvals across the US, EU, LATAM, and ASEAN markets.
• Prepared and compiled FDA 510(k) submissions for Class II Ultrasound devices, supporting multiple clearances across the US market.
• Performed regulatory impact assessments for design and software modifications, determining 510(k) applicability and documenting regulatory rationale.
• Supported labeling reviews, audit readiness, and post-market compliance activities, ensuring continued alignment with cleared indications and regulatory requirements.

Regulatory Affairs Specialist at BD (2024-01 – 2024-06)

• Supported the IVDD to IVDR transition for EU IVD products, performing gap analyses against IVDR requirements and identifying documentation and evidence shortfalls.
• Assisted with IVDR classification, conformity assessment pathway determination, and preparation of supporting rationale for Notified Body engagement.
• Coordinated IVDR technical documentation remediation activities, tracking 20+ IVDR deliverables, and supporting internal readiness for Notified Body submission and review.

Regulatory Affairs Specialist at AuramedPro Inc. (2023-01 – 2023-12)

• Supported preparation of FDA 510(k) submissions and maintenance of EU Technical Files, assisting with document compilation, formatting, and submission readiness.
• Prepared and maintained regulatory dossiers supporting APAC submissions across multiple countries, ensuring documentation alignment with local regulatory requirements.

Regulatory Affairs Associate at Lupin (2020-07 – 2022-03)

• Supported regulatory operations by maintaining controlled regulatory documentation, ensuring version control, traceability, and audit readiness across product portfolio.
• Managed document repositories and tracking tools to support submission readiness and cross-functional regulatory activities.

Master of Science in Regulatory Affairs – Northeastern University (2022-04 – 2024-04)

Doctor of Pharmacy in Pharmacy – Amravati University (2015-08 – 2020-05)