Regulatory Affairs Manager

Regulatory Affairs Manager

**+ years of experience in global regulatory affairs for medical devices, regulatory submissions to the US, EU, APAC and LATAM, regulatory and quality systems due diligence for business development, implementation of new regulatory and quality requirements. Focus on product lifecycle management, strategizing renewal and new submissions, compliance audits and change management.

Regulatory Compliance Submission Management Strategy Development Labeling and Advertising Compliance Regulatory Intelligence Audit Cross-functional collaboration Budget Problem-Solving Team Leader

Professional Experience and Achievement

Zimmer Biomet-APAC Jun 2021– Present

Regulatory Affairs Project Manager

Strategized, compiled, reviewed regulatory submissions for renewals and new to market submissions. Reviewed and approved global and local advertising and promotional materials for brochures, social media, or event specific items. Established and prioritized departmental tasks and projects. Conducted due diligence audits of third-party design owners for external alliances, mergers, and acquisitions.

Implemented loaner instrument cleaning process at the ZimmerBiomet warehouse compiling cleaning instructions from 20+ IFU’s, 3 product manuals for 12+ loaner sets.

Submitted more than 75 applications to Indian authorities for registration of more than 50 thousand SKU’s meeting the India MDR requirements.

Supported due diligence activities of 5 business development projects reviewing regulatory and quality documentation. Created integration and remediation plan for business acquisition.

Created project plan for 104 legacy external alliances across APAC countries to meet the internal procedural requirements on establishing a Quality Agreement.

QARA Project leader for new external alliances. Completed 12 new projects adding a revenue of more than USD 10M.

Brokered delivery of testing information to CFDA impacting product approvals with $200-300M revenue

Abbott Laboratories-Neuromodulation Mar 2020 – Jun 2021

Regulatory Affairs Manager

Managed new product introduction and sustaining regulatory affairs teams for mobile medical apps and legacy programmers at Abbott Neuromodulation. Reviewed promotional materials, clinical protocols, to ensure compliance to latest standards and regulatory requirements. Provided training and support to team members for daily tasks, career development and achieving business goals.

•Authored and submitted cybersecurity pre-sub requesting FDA feedback on cybersecurity ecosystem development approach.

•Co-authored 2 PMAs, 4 30-day notification, 3 Significant change notifications. Supported 3 global submissions to Canada, Australia, and Brazil.

•Recorded 1st MDR approval and FDA PMAs approval for the remote delivery of therapy management. Remote delivery of therapy set Abbott apart from its competitors as well benefit patients from tedious commutes improving patient compliance.

•Lead cross functional team to create samples for Russia type testing needs impacting product submission and launch timelines positively.

ZimmerBiomet-Surgical Apr 2014 – Mar 2020

Regulatory Affairs Associate Manager (Aug 2016 – Mar 2020)

Created and updated technical file in accordance with EU MDR requirements. Managed the labeling team and provided strategic direction to the business unit by keeping abreast of changes in the medical device regulations. Approved change orders to finished device specifications, manufacturing processes, labels, IFU’s, promotional materials including notified body notifications and design changes. Regulatory representative for CAPA, HHE and Recalls

•Lead auditor for 3 internal audits and assist with 6 external audits, quarterly UL/Intertek audits and ANVISA audits.

•Regulatory representative for 6 risk management file and 4 design file remediation projects

•Monthly average, Change Approvals – 130, Notified body notifications – 25, Worldwide change notifications – 27, 510k assessments – 10, Label approvals – 300.

•5 Due diligence projects to either acquire the business or distribute the product.

•Implemented labeling change order process to ensure there are no errors in production.

Regulatory Affairs Specialist (Nov 2015 – Jul 2016)

Lead a team to comply with FDA UDI requirements and coordinate with third parties to identify the responsibility for GTIN’s. Supported registration of medical devices OUS including EU, Asia-Pac, Africa and Central and South America. Assessed change packets to determine impact on, quality system, regulatory files and submissions.

•Implemented FDA UDI requirements including label approvals, GUDID submissions and process changes to maintain UDI compliance. Approximately 10-12 thousand label, 8-10 different procedure updates and 5-7 thousand items for Direct Part Marking

Regulatory Affairs Associate (Apr 2014 – Nov 2015)

Determined regulatory pathway for design changes, changes to manufacturing location, repair and service of devices, refurbished devices. Assisted with Canadian medical device submission and classification of device. Participated in NTL (IEC 60601-1) quarterly inspections and communicate any actions based on variance/no variance outcome. Participated in Notified body audit and FDA audit (front and back room), provided appropriate leads to SME’s and facilitate the audit to a suitable outcome. Participated in remediation activities for DHF’s, Technical Files, labeling and propose actions to either file new 510k or provide documentation with justification for no submission.

Completed a CAPA implementing a gap assessment procedure for identifying gaps within the design files or quality systems against new or updated regulations/standards. Created a matrix of regulations/standards against technical files/design files.

Completed 15 international registrations, 12 technical file updates and 500 label change approvals.

Syner-G Pharma CMC Consulting, LLC Nov 2012 – Apr 2014

Regulatory Specialist-CMC

Provided CMC regulatory support for clients to manage CMC regulatory activities including preparation and review of regulatory submissions and execution of CMC strategies. Drafted CMC sections of an IND (Investigational New Drugs), pre-IND briefing package, IND amendment and pre-NDA briefing package. IND annual reports, IND/IMPD (Investigational Medicinal Product Dossier) amendments

•Conduct gap assessment for 8 submission documents against the source documents for CDER submissions.

•Drafted CMC sections of an NDA submission.

Education

•M.S in Regulatory Affairs of Drugs, Biologics and Medical Devices

Northeastern University, Boston, April 2012

•B.S in Pharmaceutical Sciences

Mumbai University, Mumbai, India, June 2008

Certification

ISO 13485:2003 Lead Auditor (Certificate number: 825****-******) August 2015

ISO 13485:2016 Lead Auditor (Certificate number: 867****-******) March 2017

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