Director, Medical Device Industry, Healthcare

Location: Bengaluru

Job Description

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

Define clinical use cases, workflows, and user requirements for medical devices.
Identify and validate the needs for new medical devices and enhance existing devices through research and through collaboration

with experts in medical fields.

Ideal candidate will conduct market research and competitive analysis to shape customer market entry strategies and product

positioning.

Product Design And Development

Support system architects and engineers in mapping clinical requirements to features and product specifications.
Provide inputs and detailed requirements to Hardware, Software and Manufacturing teams for developing new medical devices
Manage the design and iterative development processes to meet customer needs and requirements.

Quality Assurance And Regulatory Affairs

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.

Must have good understanding of quality management systems (e.g., ISO 13485) to ensure the product development processes

are as per standards.

Should author and review Clinical Evaluation Reports (CERs) and support clinical sections of regulatory submissions (FDA 510k,

PMA, CE Mark, etc.).

Risk Management

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

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

Advise clients on selecting reliable suppliers, optimizing manufacturing processes, and ensuring compliance with good

manufacturing practices (GMP).

Required Qualifications And Skills

Education:

Advanced Medicine degree such as MBBS or Bio Medical (preferred specialization in the Cardio/pulmonary area)

Experience:

10+ years of relevant experience in guiding medical device development
Technical expertise:
Experience developing ECG/EEG and similar cardio/pulmonary devices. Knowledge of new medical devices

development, biosensors, electronics and software design.

Regulatory knowledge:
In-depth understanding of regulations like FDA 21, EU Medical Device Regulation (MDR), and ISO standards

(13485, 14971).