Add office photos
All Filters
4 CorpBiz Jobs
Asst. Manager
CorpBiz
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Quality Assurance and Qualified Lead Auditor for ISO 13485 and ISO 9001 With expertise in to register the medical devices approvals in India from CDSO and also have basic under sting of the other countries regarding medical device regulation and FDA Guidelines
- Prior approval in registration of the medical devices in India with CDSCO Authority
- Sound experience in working with Startup companies and setting up the Regulatory Affairs department.
- In Depth knowledge of various testing requirement of medical devices, Technical File / Design Dossier preparation, risk management, implementation of Quality Management System (ISO 13485 ISO 9001) etc. Able to help companies to design plant that meets international requirements.
- Have experience of dealing with DCGI (India) office for issues related to Imports, New Registrations, Clinical Trials Approvals etc.
- Specialities for medical device Regulatory Affairs, Medical Device Registration, CE Marking, Quality Management System (ISO 13485 ISO 9001), Market Strategies, Design Dossier Preparation, Risk Management, Medical Device Testing
- Lead, provide strategy and guidance, and coordinate the Regulatory Affairs initiatives within a Product group in the region to define the regulatory compliance for existing and new products marketed in the region and destine for export
- Provide thought leadership in Regulatory Affairs area in the region
- Understand, anticipate, and interpret regulatory change
- Develop and coordinate regulatory positions, requirements, and processes by working with commercial teams and Functional units (FUs), key customers, and external regulatory agencies
- Partner with PSQR colleagues to assess and implement programs and processes that enable Regulatory compliance
- Develop strong Regulatory Affairs coordination and connections across product groups and regions to ensure their continuous development which enables the capacity for executing Regulatory compliance related activities
Minimum Qualifications
- Science Degree (chemical or agricultural focus areas) or equivalent experience
- Experienced of dealing with government and trade association Technical Skills
- Demonstrated knowledge of technical in Bio-industries, chemical and or cosmetics
- Ability to provide leadership and coordination of quality efforts across the team
- Organize work and projects effectively from planning through execution
- Maintain high profile, builds long-term relationships and network of useful contacts
- Ability to prioritise and manage risk
Employment Type: Full Time, Permanent
Functional Areas: Pharma/Healthcare
Read full job description What people at CorpBiz are saying
Rating based on 1 Assistant Manager
review
Anonymous · Operations
in New Delhi
Likes
Great Working environment
Dislikes
Nothing is negative
Read 1 reviewAssistant Manager salary at CorpBiz
reported by
2
employees
with 5-6
years exp.
₹4.9
L/yr - ₹6.3
L/yr
33%
less
than the average Assistant Manager Salary in India
View more details
What CorpBiz employees are saying about work life
based on 32 employees
Flexible timing
Monday to Saturday
No travel
Day Shift
CorpBiz Benefits
View more benefits
Compare CorpBiz with
Tata Group
Compare
Reliance Industries
Compare
Aditya Birla Group
Compare
Mahindra & Mahindra
Compare
Hindustan Unilever
Compare
ITC
Compare
Infosys
Compare
Wipro
Compare
TCS
Compare
HDFC Bank
Compare
Accenture
Compare
Cognizant
Compare
Capgemini
Compare
ICICI Bank
Compare
HCLTech
Compare
Tech Mahindra
Compare
Genpact
Compare
Teleperformance
Compare
Concentrix Corporation
Compare
Axis Bank
Compare
Share an Interview