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Regulatory Affairs Specialist

Alten India
ALTEN India
2+ years
Not Disclosed
15 June 3, 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, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist


Job Description

Essential Duties & Responsibilities:

  • Document Coordination: Collaborate with Division contacts to obtain essential documents required by Taiwan RAQA during the registration process, including license and QSD applications.
  • Relationship Management: Establish and maintain a positive working relationship with Taiwan RA and Division peers to ensure timely support and document preparation.

Education & Special Trainings:

  • Degree: At least a Bachelor’s degree, preferably in healthcare, medical, engineering, or related fields.
  • Knowledge: Basic understanding of ISO 13485 and US FDA regulations related to medical devices.

Qualifications & Experience:

  • Experience: Minimum of 2 years of relevant regulatory and quality assurance experience in an international company.

Physical & Mental Requirements:

  • Detail-Oriented: Strong attention to detail.
  • Communication: Excellent communication skills.
  • Influence: Ability to motivate others to take action.
  • Ownership: Hands-on approach with the ability to implement swiftly and effectively by taking ownership and accepting responsibility.
  • Ethics: High ethical standards and integrity.
  • Organization: Well-organized with logical thinking.
  • Planning: Good at planning processes, patient, and a strong sense of responsibility.