Regulatory Specialist Lead- Medical Devices

Senior Regulatory Affairs professional with 8+ years of experience in medical devices, specializing in US FDA, EU MDR, and APAC regulations.

Proven track record in leading 510(k), PMA, and EU Technical Documentation submissions, managing audits and inspections, and driving end-to-end regulatory compliance across the product lifecycle.

Strong cross-functional collaborator, experienced in global stakeholder engagement, regulatory strategy, post-market surveillance, and mentoring teams in complex, multi-market environments.

Experience required : 8 to 12 years

Location : Pune.

To succeed in this role, you should have the following skills and experience: 

• MS or PhD in relevant field including Computer, Electrical, Mechanical Engineering, or other related science. 
• A minimum of 8 to 12 years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary. 
• Hands-on experience (technical) in ventilation is a plus. 
• Knowledge of Statistical Data Analysis is necessary. Includes ability to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power. 
• Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions  
• Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports 
• Understanding of global medical device regulatory environments and clearance processes. 
• Effective communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. 
• Experience auditing a DHF (Design History File - a compilation of records which describe the design history of a finished device) for compliance with internal processes and external standards. 
• Maintains strict confidentiality of sensitive information. 

Behaviors: The successful candidate will demonstrate the following: 

• Leadership: The ability to make things happen by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.  
• Accountability/Ownership: Work closely with team members and take ownership – be a mentor to junior engineers  
• Influence: The demonstrated ability to gain acceptance and commitment from others to one’s own beliefs and ideas. 
• Negotiating: The ability to construct and maintain a strong bargaining position to ensure positive response and agreement: striving for win-win situations. 
• Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables. 
• Data-driven decision-making: ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues. 
• Relentless focus on Quality and Transparency as an organizational value.