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Executive - Quality Assurance & Regulatory Affairs

2+ years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Executive - Quality Assurance & Regulatory Affairs
Company: Oyster Medisafe Pvt. Ltd.
Location: Hyderabad, India
Functional Area: Regulatory Affairs
Working Model: Onsite
Requisition ID: 1278

Job Description:
Oyster Medisafe Pvt. Ltd. is looking for a highly skilled and experienced Executive for our Quality & Regulatory Affairs team. The ideal candidate will be responsible for ensuring compliance with regulatory standards and managing documentation digitally. This role involves handling quality systems, liaising with drug authorities, and ensuring that products meet necessary regulations.

Key Responsibilities:

  • Regulatory Compliance: Ensure adherence to ISO 13485, CE marking, and other regulatory standards.
  • Documentation Management: Act as the document controller, maintaining and managing all quality and regulatory documentation digitally.
  • Quality Systems: Oversee the implementation and maintenance of GMP and quality management systems.
  • Liaison with Authorities: Communicate with drug authorities and other regulatory bodies to ensure product compliance and obtain necessary certifications and licenses.
  • Audits and Inspections: Prepare for and support internal and external audits and inspections.
  • Training and Development: Provide training on quality and regulatory requirements to staff.
  • Continuous Improvement: Identify areas for improvement in quality and regulatory processes and implement necessary changes.
  • Artwork Management: Ensure compliance with regulatory requirements when creating or updating artwork by collaborating with internal and external service providers.

Job Requirements:

  • Education: Bachelor's degree in Bio Engineering, Life Sciences, Engineering, or Quality Management.
  • Experience: Minimum 3-5 years in quality and regulatory affairs, preferably in the medical device or pharmaceutical industry.
  • Certifications: ISO 13485 internal auditor certification and awareness of Indian Medical Device Rules & EU Medical Device Regulations are preferred.
  • Knowledge: Strong understanding of ISO 13485, CE marking, EU MDR 2017/745, and Indian Medical Device Rules.
  • Skills: Excellent document management and system handling skills with strong communication and interpersonal abilities.
  • Attention to Detail: High level of accuracy and attention to detail in all tasks.