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Senior Technical Analyst - Healthcare
3-7 years
₹ 4.5 - 17.45L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Chennai, Pune, New Delhi + 4 more
1 vacancy
Senior Technical Analyst - Healthcare
Hexaware Technologies
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
As Butterfly expands internationally, this is an exciting opportunity to play an integral role in the development of innovative and disruptive ultrasound technology that delivers advanced medical imaging throughout the world. Be a key member of our talented and fun-loving Regulatory Affairs team working to ensure Butterfly establishes best practices in compliance and regulatory requirements on a global scale. The Senior Regulatory Affairs Specialist will support the International Regulatory Manager in prepa ring regulatory submissions for our Butterfly Ultrasound Systems and help coordinate, track, and communicate the execution of cross-functional tasks to ensure timely delivery of regulatory documents for submission to all international regulatory authorities on Butterfly s international roadmap. Come join an organization that values its people s personal and professional growth, and together we can help build the future of healthcare.
As part of our team, your core responsibilities will be:
- 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.
Qualifications
Baseline skills/experiences/attributes:
- 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.
Ideally, you also have these skills/experiences/attributes (but it s ok if you don't )
- Experience in Artificial Intelligence/Machine Learning (AI/ML) or Software as a Medical Device ( SaMD ).
- Regulatory Affairs Certification (RAC).
Employment Type: Full Time, Permanent
Functional Areas: Other
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People are getting interviews at Hexaware Technologies through
People are getting interviews through
(based on 450 Hexaware Technologies interviews)
Job Portal
Campus Placement
Walkin
Referral
Company Website
Recruitment Consultant
37%
24%
11%
8%
6%
2%
12% candidates got the interview through other sources.
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What people at Hexaware Technologies are saying
Rating based on 43 Senior Technical Analyst
reviews
Anonymous · IT Security
in Chennai
Likes
Work life balance good
Dislikes
Learning need to improve
Read 43 reviewsSenior Technical Analyst salary at Hexaware Technologies
reported by
684
employees
with 3-10
years exp.
₹4.8
L/yr - ₹18
L/yr
18%
less
than the average Senior Technical Analyst Salary in India
View more details
What Hexaware Technologies employees are saying about work life
based on 5.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Hexaware Technologies Benefits
Submitted by Company
Group Mediclaim Insurance Skill Upgradation Paid time off Rewards and Recognition
Submitted by Employees
View more benefits 
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Hexaware Technologies Chennai Office Locations
Chennai Office
Hexaware Technologies, H5, Sipcot IT Park, Navallur Post, Kancheepuram District
Chennai
Tamil Nadu 603103
Tamil Nadu 603103
Chennai Office
Hexaware Solutions Pvt. Ltd, T Nagar
Chennai
Tamil Nadu 600006
Tamil Nadu 600006
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