Philips Regulatory Affairs Specialist – BSc/MSc Life Sciences Candidates Eligible
Philips Regulatory Affairs Specialist – BSc/MSc Life Sciences Candidates Eligible. Regulatory Affairs Specialist at Philips. Latest BSc/MSc life sciences Jobs. Interested candidates can check the details below and apply online.
Job Title: Regulatory Affairs Specialist
Job Requisition ID: 501162
Location: Pune
Employment type: Full time
Job Description
Your Role:
- Compile & review the necessary local/in‐country documentation for relevant stakeholders to complete registration activities.
- Provides information entry into regulatory databases, submissions software programs, AI regulatory intelligence and decision systems, and creates reports as required.
- Preparing and maintaining product registration files to obtain or to keep marketing approval and import licenses per local Regulatory requirements for CE marked/FDA cleared devices in the countries of IGT-D’s distribution (EMEA, LATAM & APAC) to ensure that IGT-D’s products comply with the regulations.
- Ensure completion of the International Registration Schedule and report progress per established KPIs to introduce new products and keep continuous products access to the Markets, under the guidance of a country specialist or regional manager.
- Preparing regulatory filings for new products, as well as significant post market changes.
- As necessary, reviews complex regulatory issues with RA manager.
- Manage records retention (Licenses/submissions) per company policy.
- Controls the distribution approvals process for products throughout the life cycle.
Work with team members on regulatory intelligence & regulatory topics to support stakeholders. - Assists implementation of global regulatory strategy and roadmaps through understanding the competitive market landscape and product marketing strategy.
- Engages in continuous learning activities to maintain technical competence in the product areas supported.
- Adopt a First-time right submission’s culture (for Registrations, RE-Registrations and Renewals)
- Adopt an audit-ready culture.
- Identifying Process optimization to strengthen the International Regulatory Department and implement required improvements.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to RA stakeholders. Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
- Following Quality System procedures to ensure compliance with all other applicable regulations.
You’re the right fit if:
1. Experience: 5+ years of related experience, possessing a minimum of 3 years of experience in the Medical Device Industry
2. Skills: Must have working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
3. Education: Bachelor’s or master’s degree in a relevant field such as Biomedical Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline
4. Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
5. Demonstrated experience in multiple types of International regulatory submissions (Europe, South Korea, Taiwan, Kingdom of Saudi Arabia, Brazil, Russia, Australia, Mexico, Singapore, India, among others
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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 commitment to diversity and inclusion here.
Here are a few interview questions with answers for the job role of Regulatory Affairs Specialist at Philips:
1.Can you tell us about your experience in the Medical Device Industry? Answer: Certainly. I have over 5 years of experience in the Medical Device Industry, and out of that, I have specifically worked for a minimum of 3 years in regulatory affairs. During this time, I have been involved in compiling and reviewing local/in-country documentation for registration activities, preparing and maintaining product registration files to obtain marketing approval and import licenses, and handling regulatory filings for new products and post-market changes. I am well-versed in FDA, ISO 13485, EU MDR, and other regional regulations for complaint handling, incident reporting, and implementing corrective and preventative actions.
2.How have you demonstrated your expertise in handling international regulatory submissions? Answer: I have extensive experience in multiple types of international regulatory submissions across various regions, including Europe, South Korea, Taiwan, Kingdom of Saudi Arabia, Brazil, Russia, Australia, Mexico, Singapore, and India, among others. I have successfully managed the International Registration Schedule and reported progress per established KPIs to introduce new products and maintain continuous product access to markets. Additionally, I have collaborated with country specialists and regional managers to implement global regulatory strategies and roadmaps, ensuring compliance with local regulations.
3.How do you ensure compliance with company policies and maintain an audit-ready culture? Answer: Ensuring compliance with company policies is crucial in the regulatory affairs role. I achieve this by meticulously managing records retention for licenses and submissions, following Quality System procedures, and adopting a first-time right submission’s culture for registrations, re-registrations, and renewals. I understand the importance of adhering to established processes and guidelines to maintain regulatory integrity and meet the requirements of audits. This approach helps in streamlining regulatory operations and strengthens the International Regulatory Department.
4.Can you share an example of how you effectively communicated regulatory recommendations to stakeholders? Answer: Certainly. In my previous role, we encountered a complex regulatory issue regarding the introduction of a new medical device in a specific market. I researched the issue thoroughly and prepared a detailed regulatory recommendation report. To communicate this to the stakeholders, I organized a presentation, which I delivered to senior leadership and other relevant teams. I used clear and concise language to convey the regulatory implications, potential challenges, and suggested solutions. The feedback received was positive, and the recommended approach was implemented successfully, ensuring compliance and market access for the product. Effective communication is essential in regulatory affairs to maintain transparency and ensure everyone involved understands the regulatory landscape.
Editor’s Note: Philips Regulatory Affairs Specialist – BSc/MSc Life Sciences Candidates Eligible. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
