... Translate user needs, clinical requirements, and business objectives into system requirements and technical specifications. Drive compliance with Design Controls, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and applicable regulatory standards. Lead system-level risk management activities including ...
... balancing electrical, mechanical, and biocompatibility requirements while ensuring designs meet stringent safety and regulatory standards (IEC 60601, ISO 13485, FDA 510(k)/PMA pathways). Lead System Design & Engineering Lead the end-to-end design of external defibrillator electrode/lead systems, including pad electrodes, ...
... corrective/preventive actions to ensure sustained compliance. Regulatory Intelligence Maintain deep knowledge of India local requirements (e.g., CDSCO, State FDA, CBN, DSIR) and relevant global regulatory expectations (e.g. pharmacopoeial requirements such as EU/US Pharmacopeia expectations where applicable). Provide subject ...
... patent and IP strategy, including complex patent portfolios, filings and technology protection. - Lead global regulatory strategy and filings, including GRAS (US), FDA and EFSA requirements. - Build relationships with global scientific institutions, industry networks and strategic partners. - Represent the organisation with ...
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
... in account management within the healthcare or pharmaceutical industry . - Strong understanding of healthcare marketing regulations and compliance, including FDA guidelines and pharmaceutical advertising standards. - Expertise in digital marketing, social media strategies, e-commerce, and media planning. - Experience in ...
... steering committees) 3. Healthcare & Regulatory Context ● Ensure project workflows comply with applicable standards such as IEC 62304, ISO 13485, or local MDR/FDA requirements where relevant. 4. Process & Continuous Improvement - Identify and brainstorm process gaps and improvements with the stakeholders. - Conduct structured ...
Front desk manager / executive / associate (FDM / FDE / FDA) Department: Hotel operations South India (Goa, Karnataka, Kerala, Tamil Nadu) Experience: 1 to 5 years We are a people-first brand built around travel, community and shared experiences. The front desk is where The Hosteller either happens or doesn't. It is not ...
Front desk manager / executive / associate (FDM / FDE / FDA) Department: Hotel operations South India (Goa, Karnataka, Kerala, Tamil Nadu) Experience: 1 to 5 years We are a people-first brand built around travel, community and shared experiences. The front desk is where The Hosteller either happens or doesn't. It is not ...
... 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 ...
... - mandatory - Proficient in Microsoft Office - English level - advanced 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 ...
... custom formulations. - A 50,000 sq ft fully automated plant in Jaipur, scaled from a 5,000 sq ft manual operation in five years. - BRCGS Grade A, FSSC 22000, US FDA, EU Organic, USDA Organic/NOP, NPOP, Kosher, GMP, Halal and SEDEX/SMETA — more than ten active certifications. - A farmer network of 500+ certified farmers and ...
... decisions and manage multiple priorities in a highly dynamic environment. 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 ...
... supervision. - Demonstrates ethical behaviour and commitment to compliance. 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 ...
... quality - Ability to adapt to changing project requirements and priorities 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 ...
... Detail oriented with a high degree of accuracy and ability to meet deadlines. 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 ...
... meetings, investigator meetings, training, client meetings and bid defenses). 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 ...
... administrative policies and procedures, technical problems, priorities, and methods. 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 ...