Search current fda jobs, vacancies, and employment in India on Jobeax. 120 fda jobs in India.
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... requirements are incorporated into product design, development, verification, validation, and post-market activities. - Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks. - Author and maintain regulatory documentation including ...
India, Bengaluru
Ge Healthcare
... DEPS or equivalent product cybersecurity lifecycle processes in regulated industries. - Understanding of applicable cybersecurity and privacy frameworks such as FDA cybersecurity guidance, NIST, ISO 27001, IEC 81001-5-1, HIPAA, GDPR, SOC 2, or similar standards. - Experience assessing third-party products, SaaS services, ...
India, Bengaluru
... successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting. - Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11 - Proficient in Microsoft Word and Excel. - Excellent written and oral communication skills. ...
India, Itanagar
Johnson Controls
$130k USD - $401k USD / year
... needed. Preferred - Master’s degree. - PMI certification (PMP) or equivalent. - Certifications or hands-on experience in CQV; CSV awareness; familiarity with FDA 21 CFR Part 11, EU Annex 11, and related regulatory frameworks. - Specific experience delivering validated environments: GMP/GLP labs, ISO 14644 cleanrooms, ISO ...
India
675k
... level in the work environment is low. This is a largely sedentary role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India, Gurugram
... Data Manager or equivalent combination of education, training, and experience • Skills: · Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance · Experience in clinical trial databases and applications, clinical data flow, data review, and eCRF Report Form ...
India, Bengaluru
... AWS. You have experience with containerization tools such as Docker and Kubernetes. You may have experience in the medical device industry and familiarity with FDA design control processes (highly desired). Your knowledge of GCP tools like Airflow, Dataflow, and BigQuery is a plus. Experience with distributed event streaming ...
India, Bengaluru
Precision For Medicine
... Biology, Chemistry - 4 years of related experience in a life science GxP environment with CRO experience preferred - Hands-on experience with ~ ICH-GCP (E6 R2/R3) - FDA regulations (e.g., 21 CFR Part 11) - EMA / EU CTR / Annex 11 - GxP frameworks (GCP, GMP, GLP, GCLP) Preferred Certification ASQ Certified Quality Auditor (CQA) ...
India, Bengaluru
145k - 185k
Job Title: Senior Developer (Full stack) This position is for FDA & FDI Application development. The candidate should pose the relevant sound technical skills on technology like Java springs, Angular, SQL to develop code for various flagship and technical migration projects. Perform detailed technical analysis with impacts ...
India, India
675k
... or projects. - Willingness to pursue further certifications or education. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India, Hyderabad
... subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desired Statistics knowledge ...
India, Bengaluru
... execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports. - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM) and meets data integrity (ALOCOA+) principles. Well versed in commissioning and qualifying CIP & SIP systems Here's ...
India, Gurugram
... Requirements Engineering, System Architecture, Risk Management, and V&V. Experience with DOORS, Jama, Polarion, or similar tools. Knowledge of ISO 14971, ISO 13485, FDA Design Controls, and IEC 60601. Experience with FMEA, Design Controls, DHF, and technical documentation. Cybersecurity / IEC 62304 exposure is an advantage. Senior-Level ...
India, Rāniganj
80k
... proofreading skills, and the ability to communicate scientific concepts to diverse audiences. - Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review ...
India, Bengaluru
... bringing in a 'distinctive kick' that feels & tastes like freshly grounded coffee. The company has created craft coffee that is instantly consumable, affordable - ready to mix - and is convenient to carry in tube shots. Rage Coffee products are also US FDA, FSSAI, ISO registered and manufactured at a GMP compliant facility.
India, Delhi
675k
... create a place where everyone feels like they belong. Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India
675k
... to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India, Gurugram
675k
... to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India, Hyderabad
675k
... communication skills. - Ability to read, write, speak and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
India
... level for at least one Project. Technical Skills: - Experience with paperless validation software such as KNEAT and/ or Valgenesis. - In-depth knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements. - Strong project management skills with the ability to handle multiple priorities across national and international ...
India, Gurugram