India Principal Regulatory Associate

Apple Inc.; India; Hybrid; INR 1,500,000 - 2,100,000; Full time

Job summary

Apple Inc. is seeking a Principal Regulatory Affairs Associate to lead regulatory strategy, submissions, and policy for health products in India and surrounding geographies.

The role requires building regulatory plans, managing risk assessments, and coordinating with cross-functional teams to secure approvals for innovative health technologies. The position involves working on regulatory filings, pre-submissions, and SEC meetings, with emphasis on SaMD and algorithm-based devices, while

Qualifications

• Bachelor's in engineering discipline is required.
• 10+ years medical device regulatory experience, incl. 5+ years as principal/lead.
• Significant experience with CSDSCO interactions and regulatory filings.
• Experience with SaMD and algorithm- or sensor-based products.

Responsibilities

• Represent RA/QA on regulatory submissions and policy initiatives to obtain approvals for new health technologies in India and nearby geographies.
• Develop regulatory plans considering risks, mitigations, and regulatory actions.
• Lead interactions with regulatory bodies and prepare pre-submissions and SEC meetings.

Skills

Regulatory strategy

Policy development

SEC meetings

SaMD knowledge

CDSCO regulations

Education

Bachelor's in engineering (Mechanical / Electrical / Biomedical / CS)

Job description

Imagine what you could do here. At Apple, excellent ideas have a way of becoming great products, services, and customer experiences. Bring passion and dedication to your job, and there’s no telling what you could accomplish. The people at Apple don’t just build products — we craft the kind of wonder that’s revolutionised entire industries.The Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy, submissions, and policy for health products in India and surrounding geographies. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. We come to Apple to think creatively about how to launch products within a rigorous regulatory structure for medical devices.

Description

You will represent the RA/QA team on a diverse array of regulatory submissions and policy initiatives with the goal of obtaining approvals for new technologies and making an impact in health policy. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class A, B, and C products including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in India and surrounding geographies.

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

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