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Director, CMC, FDA Experience (EMEA/INDIA)

Allucent  –  Tata Nagar, Andhra Pradesh, 517501, India
... The Director, CMC leads and/or participates in Health Authority (HA) communications including correspondences with the FDA and EMA, and reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, ... - May 05

Director, CMC, FDA Experience (EMEA/INDIA)

Allucent  –  India
... The Director, CMC leads and/or participates in Health Authority (HA) communications including correspondences with the FDA and EMA, and reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, ... - May 05

Engineering Manager

Aurolab  –  Madurai, Tamil Nadu, India
... Collaborate with stakeholders to ensure alignment between product development and user needs Regulatory Compliance: Demonstrate a thorough understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards. ... - Apr 21

Engineering Manager

Aurolab  –  India
... Collaborate with stakeholders to ensure alignment between product development and user needs Regulatory Compliance: Demonstrate a thorough understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards. ... - Apr 21

Laser Engineer

Aurolab  –  India
... Familiarity with medical device regulations and standards, such as FDA 21 CFR Part 820, ISO 13485, and IEC 60601. Excellent problem-solving skills and the ability to work effectively in a multidisciplinary team environment. Effective communication ... - Apr 20

Laser Engineer

Aurolab  –  Madurai, Tamil Nadu, India
... Familiarity with medical device regulations and standards, such as FDA 21 CFR Part 820, ISO 13485, and IEC 60601. Excellent problem-solving skills and the ability to work effectively in a multidisciplinary team environment. Effective communication ... - Apr 20

Senior Hardware Engineer

Aurolab  –  India
... Familiarity with regulatory standards and requirements for medical devices, such as IEC 60601, ISO 13485, and FDA 21 CFR Part 820. Experience with design verification and validation testing, including electrical testing, EMC/EMI testing, and safety ... - Apr 20

Senior Hardware Engineer

Aurolab  –  Madurai, Tamil Nadu, India
... Familiarity with regulatory standards and requirements for medical devices, such as IEC 60601, ISO 13485, and FDA 21 CFR Part 820. Experience with design verification and validation testing, including electrical testing, EMC/EMI testing, and safety ... - Apr 20

Vigilance Specialist

Resmed  –  India Gate, Delhi, 110011, India
... Familiarity with FDA regulations is preferred. Knowledge in managing of vigilances and associated processes. 3-5 years of experience in the medical device industry or a regulated environment Competent in Office (Word, Microsoft Excel, ...) Familiar ... - May 04

New product development

Wellbeing Nutrition  –  Mumbai, Maharashtra, India
To be well versed with FSSAI, FDA, AYUSH regulations and guidelines. • Proposes new product ideas via market study and evaluates formulation strategies for Research and Development compounds. • Experienced in product development such as protein ... - Apr 19
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