Architect – Product Safety & Regulatory Engineering
On-siteBengaluru, Karnataka, India
Job Summary
Lead Product Safety, Regulatory Compliance, Risk Management, and Design Controls for X-Ray Tube and X-Ray Generator portfolios across the entire product lifecycle. Evaluate engineering, supplier, and manufacturing changes to ensure continued compliance with global regulatory requirements. Lead product risk management activities including Hazard Analysis, DFMEA, PFMEA, and Product Safety Reviews, while driving PSRB activities and Country Compliance Notifications. Review and approve technical documentation such as Technical Files, Design History Files, and Device Master Records throughout the Design Control process. Collaborate with cross-functional teams to support internal and external audits, resolve technical compliance issues, and drive continuous improvement initiatives. Requires 10+ years of experience in medical device regulatory engineering and design controls. Onsite role with relocation assistance provided.
Required Qualifications
- Bachelor's or Master's degree in Electrical Engineering, Electronics Engineering, Mechanical Engineering, or a related engineering discipline
- Minimum of 10 years of experience in Product Safety, Regulatory Engineering, Design Controls, Quality Engineering, Medical Device Compliance, or a related technical discipline
- Demonstrated knowledge of medical device regulations and standards, including IEC 60601, ISO 14971, ISO 13485, FDA regulations, EU MDR, NMPA, CDSCO, and other applicable global regulatory requirements
- Experience with Design Controls, design change management, risk management, verification and validation, product lifecycle management, and regulatory compliance
- Working knowledge of EMI/EMC requirements and product certification processes
- Experience supporting complex medical devices, preferably X-Ray Tubes, X-Ray Generators, medical imaging systems, or related electromechanical products
Desired Qualifications
- Strong technical leadership with a systems engineering mindset
- Demonstrated ability to influence and collaborate across global cross-functional teams
- Excellent analytical, problem-solving, and risk-based decision-making skills
- Strong written and verbal communication skills with the ability to communicate complex technical concepts to diverse stakeholders
- Experience balancing innovation, quality, regulatory compliance, and business objectives
- Self-motivated with a continuous improvement mindset and strong execution focus
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