Add office photos
All Filters
201 Mobiquity Jobs
Senior Technical Analyst - Healthcare
4-9 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Senior Technical Analyst - Healthcare
Mobiquity
posted 2d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Build comprehensive regulatory submissions based on input from cross-functional teams and manage the execution of timelines and regulatory deliverables.
- Maintain regulatory submissions/renewals according to country registration requirements to facilitate product approvals on a global scale.
- Clearly and concisely communicate registration status and provide early visibility into risks/issues to enable timely action.
- Escalate registration risks, resource needs, priority conflicts, etc. to appropriate program and functional managers.
- Help lead regulatory discussions on country specific requirements and provide feedback to senior regulatory management.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Help track advertising, promotional, and labeling materials and ensure timely delivery of marketing assets to international markets.
- Maintains a knowledge base in domestic and international regulatory policy, regulation and initiatives.
- 5+ years of experience in a regulated industry.
- Bachelors degree in Scientific, Engineering, Regulatory, or core Life Science discipline. M.S. in a technical area or M.B.A. is preferred.
- Experience with successful preparation and submissions of Technical Documentation and/or global registrations of medical devices.
- Excellent understanding of international requirements ( e.g. EU MDR) and experience expanding into multiple international regions such as EU, APAC, MEA, LATAM, etc.
- Strong verbal and written communication and presentation skills, with the ability to speak and write clearly and convincingly in English.
- Strong organizational, analytical, and strategic thinking skills.
- Exercises good and ethical judgment within policy and regulations.
- A team player and collaborator with a service-oriented approach who is also flexible and proactive towards changing needs.
- Experience in Artificial Intelligence/Machine Learning (AI/ML) or Software as a Medical Device ( SaMD ).
- Regulatory Affairs Certification (RAC).
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Senior Technical Analyst roles with real interview advice
People are getting interviews at Mobiquity through
People are getting interviews through
(based on 1 Mobiquity interview) What people at Mobiquity are saying
What Mobiquity employees are saying about work life
Mobiquity Benefits
View more benefits
Compare Mobiquity with
Persistent Systems
TCS
Infosys
Wipro
HCLTech
Tech Mahindra
LTIMindtree
Mphasis
Hexaware Technologies
VDart
Magic Edtech
Saama Technologies
DISYS
Data-Core Systems
Arvato
Xchanging
11:11 Systems
Zen3 Info Solutions
Calpion Software Technologies
Tangoe
Similar Jobs for you
Senior Technical Analyst - Healthcare
4-9 Yrs
Kolkata, Mumbai, New Delhi +4 more
Microsoft Cloud Native Lead - FSD_AWS
7-11 Yrs
Kolkata, Mumbai, New Delhi +4 more
Senior Domain Consultant - Banking
5-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
