Minhaaz Dadabhai

Regulatory Affairs Professional experienced within the RA/QA domain, worked with multiple medical devices classified as Class I, Class IIa, IIb and Class III and various software devices under the EU MDD/MDR, CMDR, 21 CFR 820 and SOR/98-282.

Experience in preparing and leading the organisation for QMS/Regulatory audits as a management representative, and Technical File Audits. Interact with and provide guidance and knowledge for multi-disciplinary teams/stakeholders within the company regarding regulations and standards.

Experience in leading multi-disciplinary teams in a variety of projects (13485 transition, UDI implementation, MDSAP, MDD-MDR, CE marking etc.). Completed transition from CMDCAS to MDSAP. Competent regulatory professional as per the definitions set out within MDR 2017-745 EU.

Senior Regulatory Affairs Specialist - CooperVision Ltd.

(2022-01 - 2026-03)

Contract position

• Produce and review technical and regulatory documentation in accordance with ISO 13485:2016, MDD 93/42/EEC and MDR 2017/745 EU.
• NPD product introduction in compliance with MDR.
• Managing and maintaining regulatory submissions to gain market access.
• Preparing and submitting Technical Documentation to notified body for MDR certification.
• Maintaining MHRA device registrations.

Senior Regulatory Affairs Specialist - Smith & Nephew Plc.

(2020-09 - 2022-01)

Contract position

• Creating and reviewing technical files as per NPD and Technical File update schedules.
• Assessment of changes in compliance with NBOG 2014-3 and Article 120 of MDR 2017/745.
• Creation, and maintenance of high quality regulatory compliant documentation, as needed for all classes of products (Risk Management Reports, Post Market Surveillance, Essential Requirements and GSPRs as under EU MDR etc.)
• NPI introduction of SAMD device.

Regulatory Affairs Manager - Vernacare Ltd.

(2019-09 - 2020-09)

• Responsible for all aspects of Registration, Regulatory Affairs and Regulatory Compliance on a global (US & EU) basis, including management of the regulatory department, and preparation for Marketing approvals (NDA/MAA)
• Project lead for transition of CMDCAS to MDSAP (Health Canada).
• Working experience in the following under EU MDR: Compliance to GSPR – Annex I, EU MDR; Technical Documentation as per Annex II, EU MDR; Biological Evaluation (10993-1:2018); Implementation of Post Market Surveillance System (Vigilance, Plans, PSURs etc.); Listed as responsible person under EU-MDR within QMS system.
• Responsible Regulatory Professional on-site (MDR 2017-745 EU).
• CE marking (Pre-Market and Post Market).

Regulatory Affairs Specialist - Vernacare Ltd.

(2018-03 - 2019-09)

• Creation, and maintenance of high quality regulatory compliant documentation, as needed for all classes of products (Risk Management Reports, Post Market Surveillance, Essential Requirements and GSPRs as under EU MDR etc.)
• CE marking (Pre-Market and Post Market).
• Ensure pre-market clearances are achieved in a timely manner and ensure timescales and regulatory pathways are fully understood.
• Assist with Corrective action review requests, change controls, non-conformities.
• Produce and review the technical and regulatory documentation in accordance with ISO 13485:2016, MDD 93/42/EEC and MDR 2017/745 EU.

Regulatory Affairs Specialist - UK Labs Ltd.

(2016-03 - 2018-02)

• Provided applicable documentation for both domestic and international regulatory submissions.
• Specifying quality requirements of raw materials with suppliers.
• Working with operating staff to establish procedures, standards, systems and procedures.
• Construct and Maintain technical file for all classes of products (Class I – Class IIa) using GAP analysis techniques to ensure compliance to standards and regulations, prior to notified body audits (Class IIa Disinfectant Rule 15).
• Assist with Corrective action review requests, change controls, non-conformities.
• Reviewed device labelling and advertised materials in adherence with submissions.
• Developed document dossiers for regulatory submissions.
• Developed and submitted applications for relevant State and federal licensing.
• Ensure TCAR (Technical File Car Requests) are completed in a timely manner.

Regulation and Development Scientist - Liberty Flights Ltd.

(2015-03 - 2016-03)

• Devising new processes, or refining existing ones to optimise manufacturing processes.
• Planning, carrying out and supervising testing protocols in laboratory.
• Ensuring conformity with incoming regulations from the Medical Health Regulations Agency.
• Worked within an ISO9001 environment and keeping up to date with REACH, CLP and RoHS legislations.

BSc (Hons) - Chemistry - University of Central Lancashire