PMS Business Expert

Location: Pune

Job Title

Job Title: PMS Business Expert

Job Responsibilities

Conduct Health Hazard Evaluations, periodic risk reviews, benefit-risk assessments, and other product-safety and risk-management evaluations.

Ensure adherence to applicable product-safety and risk-management processes, regulations, standards, and organizational procedures. Use approved tools and systems to document, track, and analyze product risks

Evaluate whether post-market information affects existing hazards, hazardous situations, risk estimates, risk controls, residual-risk conclusions, or overall benefit-risk acceptability.

Ensure timely and accurate product performance information is available to enable actionable decisions that drive product designs and improvements.

Collaborates within cross-functional teams in the investigation of commercialized medical devices in the field.

Conducts comprehensive risk assessments and assists in identifying effective mitigation strategies to safeguard the patient, user and consumer safety for the business.

Review of complaint files for applicability in risk review, adverse-event related incidents, vigilance data and input into field actions and recalls

Serve as key partner and liaison between Medical Affairs, Clinical Affairs, Research and Development and Complaint Handling and other relevant functions to ensure performance information is available to enable actionable decisions that drive product designs and improvements that delight our customers.

Collaborate with design, manufacturing, and supplier teams to perform root cause analysis on defects, utilizing root cause analysis concepts to investigate issues related to commercialized medical devices in the field and implement Corrective and Preventive Actions (CAPA) including effectiveness checks.

To succeed in this role, you’ll need a customer-first attitude and the following

Bachelor’s/Master’s degree in medical sciences/Engineering/Life sciences is required.

8+ years of medical device industry experience.

Experience in Risk management preferred

Exposure to CAPA added advantage

Process improvement capabilities and experience.

Strong written and verbal communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).

Ability to successfully balance and prioritize multiple concurrent projects and tasks.

In-depth knowledge of Quality Management Systems (QMS).

Proven work experience and knowledge with medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, including the Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169

Demonstrates collaborative patient and customer focus.

Experience interacting with the FDA, ISO, and Other Regulatory Authorities.

Excellent communication, analytical, and problem-solving skills

In-depth knowledge of medical terminology.

Preferred Skills

Post Market Surveillance Mechanisms

Health and Safety Monitoring

Quality Management Systems (QMS)

Quality Specifications • Data Analysis & Interpretation

Regulatory Requirements

Technical Documentation

CAPA Methodologies

Continuous Improvement

KPI Management

Quality Risk Management

Reliability Engineering

Product Risk Management

Business Acumen

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

About Philips

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.