Executive Regulatory Affairs Webbizzare

About Webbizzare

Job Description

Major Duties & Responsibilities: Assist in Preparing, controlling, distribution, implementation, and maintaining QMS documents, including Standard Operating Procedures (SOPs), work instructions, formats, and policies, ensuring alignment with standards such as EN ISO 13485. Assist in structuring and implementing various quality-related procedures, systems, and activities. Assist in preparing all documents complying with quality and regulatory requirements. Ensure proper filing and retrieval of QA-related documents. Identify deviations and non-conformances, raise Non-Conformance Reports (NCRs), and oversee their resolution. Review and release batch manufacturing records, Certificates of Analysis (COA), and Certificates of Compliance (COC) before dispatch to ensure compliance with quality standards. Develop and deliver training materials, including questionnaires and answer sheets, to ensure staff are knowledgeable about QMS requirements. Provide Support with internal and external audits, ensuring the organization complies with regulatory standards and customer requirements. Assist the HOD in day-to-day task. Required Skill Set: Excellent analytical and problem-solving skills. Attention to detail and strong organizational skills. Effective communication and interpersonal skills for cross-functional collaboration. Ability to learn quickly and adapt to a dynamic work environment. Interested Can Wataspp at 9540247767 Job Type: Full-time Benefits: Cell phone reimbursement Health insurance Schedule: Day shift Performance bonus Quarterly bonus Shift allowance Yearly bonus Application Question(s): M.SC/Diploma in Regulatory Affairs Education: Master's (Preferred) Work Location: In person,