PMS Business Expert

Philips; Pune; On-site; INR 2,200,000 - 3,600,000; Full time

Job summary

Philips in Pune seeks a PMS Business Expert to lead health hazard evaluations, risk management and CAPA in medical devices. You will collaborate across Regulatory, Medical Affairs, R&D and Complaint Handling to ensure safety and performance.

You should hold a Bachelor’s or Master’s in medical sciences, engineering, or life sciences, with 8+ years in medical devices and strong English communication. Familiarity with QMS and major regulations is preferred.

Qualifications

• Bachelor’s/Master’s degree in medical sciences, engineering or life sciences.
• 8+ years of medical device industry experience.
• Experience in risk management preferred.
• Exposure to CAPA is an added advantage.
• Strong communication of technical content to varied audiences.

Responsibilities

• Conduct health hazard evaluations and risk assessments.
• Document, track and analyze product risks using approved tools.
• Evaluate post-market information affecting hazards and risk estimates.
• Provide timely product performance information for design improvements.
• Collaborate with cross-functional teams on CAPA and field actions.
• Root cause analysis with design, manufacturing and supplier teams.

Skills

English comms

Regulatory liaison

CAPA expertise

Risk management

Education

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

Tools

QMS knowledge

21 CFR knowledge

ISO 13485 knowledge

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

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.