PMS Business Expert

Philips; Pune District; Hybrid; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Job summary

Philips is seeking a PMS Business Expert in Pune for medical device risk management. The role focuses on health hazard evaluations, risk assessments, CAPA, and ensuring compliance with global regulations.

You will work with cross-functional teams to safeguard patients and customers and support improvements in product safety and quality. Applicants should have 8+ years in the medical device field, strong English communication, and a deep understanding of QMS and regulatory standards, including

Qualifications

• Bachelor’s or Master’s in medical sciences, engineering or life sciences.
• 8+ years of medical device industry experience.
• Experience with risk management and CAPA.
• Knowledge of global medical device regulations and standards.
• Strong written and verbal English communication.

Responsibilities

• Conduct Health Hazard Evaluations and risk reviews.
• Document and analyze product risks using approved tools.
• Assess post-market information and risk controls.
• Provide data to drive product designs and improvements.
• Collaborate with cross-functional teams on investigations of devices in the field.
• Lead CAPA investigations and effectiveness checks.
• Review complaint files for risk and vigilance data.
• Coordinate with Medical Affairs, Clinical Affairs, R&D and Complaint Handling.
• Work with design, manufacturing and suppliers to perform root cause analysis.

Skills

Risk management

CAPA

QMS

Regulatory compliance

Documentation

Cross-functional collaboration

English communication

Analytical thinking

Education

Bachelor’s/Master’s degree in medical sciences/Engineering/Life sciences

Job description

Job Title

PMS Business Expert

Job Description

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

Learn more about our business, discover our rich and exciting history and learn more about our purpose. Learn more about our culture of impact with care.