Director

Job Title: Clinical Product Owner
Location: Bangalore
Experience: 10+ years

Role Overview:
We are seeking a visionary and accomplished Medical Device Clinical Product Owner to lead our new product development initiatives in
Healthcare and Life sciences. This role combines deep functional expertise with strong leadership and business acumen. The ideal candidate will have a proven track record in conceptualizing, evaluating, and developing medical systems. You will liaison with medical practitioners, OEM
partners and cross-functional engineering teams to guide solution development and implementations. This is a customer-facing role with a strong focus on innovation, solution development, and strategic growth initiatives.

Core Responsibilities
Research and technology consultation:
o Define clinical use cases, workflows, and user requirements for medical devices.
o Identify and validate the needs for new medical devices and enhance existing devices through research and through collaboration
with experts in medical fields.
o Ideal candidate will conduct market research and competitive analysis to shape customer market entry strategies and product
positioning.
Product design and development:
o Support system architects and engineers in mapping clinical requirements to features and product specifications.
o Provide inputs and detailed requirements to Hardware, Software and Manufacturing teams for developing new medical devices
o Manage the design and iterative development processes to meet customer needs and requirements.
Quality assurance and Regulatory Affairs:
o Should have a solid understanding of the regulatory frameworks (like FDA regulations in the U.S.) required for the medical device
and should manage submissions for product approval.
o Must have good understanding of quality management systems (e.g., ISO 13485) to ensure the product development processes
are as per standards.
o Should author and review Clinical Evaluation Reports (CERs) and support clinical sections of regulatory submissions (FDA 510k,
PMA, CE Mark, etc.).

Risk management:
o Should be capable of assessing potential risks associated with a device and develop strategies to mitigate them, ensuring the
device is safe and effective for end-users.
Clinical trials:
o Must assist in managing clinical trials to test a device's safety and efficacy, as well as prepare the necessary documentation for regulatory submissions.

Supplier and manufacturing support:
o Advise clients on selecting reliable suppliers, optimizing manufacturing processes, and ensuring compliance with good
manufacturing practices (GMP).

Required Qualifications and Skills:
o Education: Advanced Medicine degree such as MBBS or Bio Medical (preferred specialization in the Cardio/pulmonary area)
o Experience: 10+ years of relevant experience in guiding medical device development
o Technical expertise: Experience developing ECG/EEG and similar cardio/pulmonary devices. Knowledge of new medical devices
development, biosensors, electronics and software design.
o Regulatory knowledge: In-depth understanding of regulations like FDA 21, EU Medical Device Regulation (MDR), and ISO standards
(13485, 14971).