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India Principal Regulatory Associate

Apple· Software and Services
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Hybrid (Gurugram)full-timePosted 1mo ago

About the role

Principal Regulatory Affairs role in Apple’s Health group focusing on strategy, submissions, and policy for health products in India and surrounding geographies. Responsible for regulatory submissions, policy initiatives, and developing regulatory plans for Class A, B and C medical devices and SaMD, working with a globally dispersed team in a hybrid in-person role.

Responsibilities

  • Represent the RA/QA team on regulatory submissions and policy initiatives to obtain approvals for new technologies and impact health policy.
  • Assess regulatory impact for new and modified Class A, B, and C products including identifying assumptions/risks/mitigations and developing executable regulatory plans in India and surrounding geographies.
  • Lead interactions with CSDSCO and prepare regulatory filings including pre-submissions and Subject Expert Committee (SEC) meetings.
  • Drive policy initiatives in the medical device and Software as a Medical Device space; craft policy and advocacy positions, memos, and briefing documents.
  • Collaborate with engineering teams to set regulatory strategy; partner with globally dispersed teams to determine appropriate global regulatory requirements for new products or changes.

Qualifications

  • Bachelor's in Mechanical/Electrical/Biomedical/Computer Science or equivalent engineering discipline
  • 10+ years of medical device regulatory experience, including at least 5+ years in a principal/lead role
  • Significant experience leading interactions with CSDSCO
  • Experience preparing regulatory filings including pre-submissions and SEC meetings
  • Experience driving policy initiatives in medical devices and SaMD; strong policy/advocacy drafting skills
  • Strong working knowledge of CDSCO regulations for Class A, B, C devices
  • Experience with SaMD and algorithm- or sensor-based products; understanding regulatory strategy and clinical study design interactions
  • Ability to be onsite; hybrid in-person position
  • Global regulatory strategy experience (e.g., EU MDR) is a strong plus
  • Autonomous, goal-driven with minimal supervision
  • Experience working as part of a globally dispersed team
  • Proven ability to determine global regulatory requirements for new products or changes
  • Effective collaboration with engineering teams to set regulatory strategy
  • Strong organizational and management skills
  • Excellent verbal and written communication skills

Skills

Required:Regulatory strategyCSDSCO interactionsRegulatory submissionsSaMD regulatory
Nice to have:Policy and advocacy

Benefits

  • See job description for accessibility and benefits emphasis at Apple
Last updated Sep 11, 2026. Interested? Apply on the company site.

About Apple

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

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