Regulatory Lead, Medical Devices
1 week ago
Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets).
Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations.
Oversee regulatory strategy, project planning, and execution for medical device submissions.
Provide guidance on Quality Management Systems (QMS) and support audits/inspections.
Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives.
Take ownership of projects, demonstrating leadership and accountability in delivery.
4–6 years of experience in medical device regulatory affairs .
~ Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations .
~ Experience in responding to Health Authority queries and managing regulatory communications.
~ Excellent project management, organizational, and leadership skills.
~ Opportunity to lead regulatory projects across global markets.
Be at the forefront of advancing compliance and patient safety in medical devices.
Apply now via LinkedIn or connect with us to explore this opportunity
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Medical Device Regulatory Lead
1 day ago
Hyderabad, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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Medical device regulatory lead
2 weeks ago
Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other...
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Medical Device Regulatory Lead
2 weeks ago
Hyderabad, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other...
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Medical Device Regulatory Lead
6 days ago
Hyderabad, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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Medical Device Regulatory Lead
1 week ago
Hyderabad, India ArtiXio Full timeAbout the RoleWe are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other...
-
Medical Device Regulatory Lead
1 week ago
Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
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Medical Device Regulatory Lead
2 weeks ago
hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
-
Medical Device Regulatory Lead
2 weeks ago
Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
-
Medical Device Regulatory Lead
2 weeks ago
Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO, and other global...
-
Medical Device Regulatory Lead
5 days ago
Hyderabad, India ArtiXio Full timeAbout the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other...
