170 Job openings found

Regulatory Affairs Executive – Medical DevicesExperienced Regulatory Affairs Executive with strong expertise in Medical Writing, EU MDR 2017/745 compliance, and regulatory documentation for Class IIb & Class III Implantable Intra Ocular Lens (IOL) devices. Skilled in handling Clinical Evaluation documentation, Technical Files, Risk Management, Post-Market Surveillance, and QMS documentation in ...

Role OverviewA Singapore-headquartered financial services organisation is setting up its operations in GIFT City (IFSCA jurisdiction) and is looking to hire a Compliance Officer to support regulatory setup, statutory coordination, and operational compliance execution for its India entity.This role is best suited for professionals with 3–5 years of compliance experience, ...

Role: • Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • ...

Role OverviewWe are seeking highly motivated and passionate individuals with expertise in Australian accounting, taxation and SMSF services to join our dynamic team. If you have a strong background in accounting and tax, a desire to learn and grow in the field of Australian taxation, and a commitment to delivering ...

We are seeking a proactive and adaptable Compliance Manager (US Market) to ensure our company's compliance with regulations across different states in the US market. The ideal candidate will possess a basic understanding of US market rules and regulations and be prepared to conduct research and collaborate with cross-functional teams ...

Knowledge of  Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4. Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk. Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses ...

Responsibilities: Develop and implement operational strategies, goals, and objectives in alignment with the company's mission and vision. Create operational plans, budgets, and timelines to achieve organizational targets and deliver excellent customer service. Monitor and evaluate operational performance, identify areas for improvement, and implement appropriate changes. Ensure compliance with regulatory requirements and industry standards. Assess current ...

Quality Assurance Specialist Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...

Job Description:We are seeking an experienced Level 3 (L3) Engineer with 4 to 8 years of hands-on experience in Linux environments. The ideal candidate should possess strong knowledge of Linux systems, networking settings in Linux, Linux security concepts, and data encryption at rest. Experience with Vormetric Data Security Manager or ...

To manage and oversee financial accounting, auditing, taxation, budgeting, and compliance functions to ensure accurate financial reporting and regulatory adherence while providing strategic financial insights for business growth. Key Responsibilities:Prepare and review financial statements, ensuring compliance with accounting standards and regulatory requirements.Conduct internal and external audits and coordinate with auditors for ...