India Principal Regulatory Associate

Description

Minimum Qualifications

• Bachelor's in Mechanical/Electrical/Biomedical/Computer Science degree or equivalent in any engineering discipline
• 10+ years of medical device experience in a regulatory role, with at least 5+ years as a principal, manager or lead.
• Significant experience in leading interactions with CSDSCO.
• Significant experience preparing regulatory filings including pre-submissions and Subject Expert Committee (SEC) meetings.
• Experience driving policy initiatives in the medical device and Software as a Medical Device space.
• Expertise in crafting policy and advocacy positions, memos, and briefing documents.
• Strong working knowledge of CDSCO regulations that affect Class A, B and C devices.
• Experience with Software as a Medical Device (SaMD) and algorithm- or sensor-based products, including how regulatory strategy interacts with clinical study design and algorithm performance.
• Ability to be onsite; this role is a hybrid, in-person position.

Preferred Qualifications

• Global regulatory strategy experience (e.g., EU MDR) is a strong plus.
• Demonstrable background in being autonomous and being able to clearly work towards established goals and initiatives with minimal oversight.
• Working as part of a globally dispersed team.
• Proven competence in determination of appropriate global regulatory requirements for new products or product changes.
• Partnering with and across engineering teams to set regulatory strategy.
• Strong organisational and management skills.
• Excellent communication skills, both verbal and written