ABOUT THE COMPANY
Wrig Nanosystems is a rapidly growing medical device start-up with focus on cutting edge
bioelectronics based medical diagnostics. We focus on developing advanced intellectual
properties and their derived products.
The company has been awarded by the Government of India as the "Indian Medical Device
Company of the Year" in the year 2021.The company has a series of new globally advanced
technologies in the pipeline and is progressing towards becoming a global giant in
personalized diagnostics.

Detailed view of our product and vision can be accessed at https://truehb.com/

 

Job Summary and Responsibilities:

Job Summary:

We are seeking an experienced Regulatory Affairs Specialist to oversee regulatory
compliance for medical devices, combination products, and procedure packs. The ideal
candidate will have expertise in global regulatory submissions, compliance with
international standards, and project management.

Key Responsibilities:

 Manage regulatory submissions for medical devices and in-vitro medical devices.
 Lead regulatory projects, ensuring coordination with internal teams, notified bodies,
and regulatory authorities.

 Prepare applications for new medical device licenses, post-approval changes, and
timely renewals in compliance with EU-MDR/IVDR, IMDR, HSA, and ASEAN Medical
Device Directives.
 Ensure compliance with international standards such as ISO 13485, ISO 14971, ISO
10993, IEC 62366, IEC 62304, ISO 15223, ISO 20417, and ISO 60601.
 Apply for NCC, MSC, and FSC for both manufactured and imported products.
 Support the tender team in bid submissions and GEM Portal processes.
 Handle regulatory activities related to export and post-approval changes.
 Oversee artwork preparation and revisions in compliance with EU-MDR/IVDR,
USFDA, IMDR, ISO 20417, ISO 18113 and ISO 15223 requirements.
 Conduct internal audits to ensure compliance with company policies and regulatory
standards, while also managing external audits, including ISO 13485.
 Respond to regulatory queries from notified bodies (BSI, TUV, DNV) and other
regulatory authorities.
 Maintain a strong understanding of medical device regulations and quality
management system requirements.
 Stay up to date with industry trends, emerging regulations, and regulatory strategies.

 

QUALIFICATIONS AND EXPERIENCE REQUIRED

Technical Skills:

 Extensive experience in regulatory affairs within the device industry.
Behavioural Skills
1) Leadership,
2) Self-start-up,
3) Team player,
4) Analytical problem-solving skill,
5) Learning orientation,
6) Creative and capable to work in a challenging environment.

Preferred Experience
Minimum 2 years of experience in Medical Devices/Invitro Medical Devices
Should have knowledge of USFDA and EUMDR