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2 Philips Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist
Philips
posted 11hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU, Canada and Asian countries [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada, NMPA, JPAL].
- Collaborate with worldwide colleagues regarding license renewals and updates
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Communicate application progress to internal stakeholders
- Maintain regulatory files and tracking databases as required
- Good Understanding of UDI/ EUDAMED and GTINs
- Communicate with regulatory agencies as needed
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
- Local Item Creation / Item Setup in the ERP with focus on local requirements.
Youre the right fit if: (4 x bullets max)
- Bachelors degree in a software, technical, or biomedical discipline
- Minimum of 2-4 years of experience in medical device regulated environment.
- Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
- Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
- Experience in supporting international registrations (FDA) and clinical investigations (preference)
- Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference)
- Knowledge of the NMPA requirements. (preference)
- Excellent verbal and written communication skills (English)
- Enthusiastic, self-motivated regulatory professional
- Good communicator and team player who can work in a flexible and goal-oriented environment
- Structured way of working
- Problem-solving and time management skill
Employment Type: Full Time, Permanent
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What Regulatory Affairs Specialist at Philips are saying
Rating based on 1 Regulatory Affairs Specialist
review
Anonymous · Other
in Pune
Likes
Projects, salary.
- Salary - Good
+6 more
Dislikes
Work like balance, management
Regulatory Affairs Specialist salary at Philips
reported by
11
employees
with 5-12
years exp.
₹9.2
L/yr - ₹20
L/yr
70%
more
than the average Regulatory Affairs Specialist Salary in India
View more details
What Philips employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
View more benefits
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Philips Pune Office Location
Pune Office
Philips Medical System, No.6, 2nd Floor, Dinkar Smruti, Shivajinagar, Bhamburda
Pune
Maharashtra 411005
Maharashtra 411005
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