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Regulatory Affairs Associate

Persolkelly
0-5 years
Not Disclosed
15 June 10, 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, 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

Job Title: Regulatory Affairs Associate

  • Company: PERSOLKELLY
  • Client: 3M

Job Overview:

  • Duration: 12 months maximum term contract with high potential for extension
  • Remuneration: Competitive package

About the Company:

PERSOLKELLY brings together the legacy and experience of Kelly Services, SKILLED, Programmed, and PERSOLKELLY, offering workforce solutions across APAC. 3M, established in 1902, is a global leader driven by science, innovation, and integrity.

Role Responsibilities:

  • Support transition of Health Care Business products for ANZ to new legal entity.
  • Develop and maintain documentation related to risk assessment for human health and environment.
  • Prepare and file regulatory documents.
  • Update internal database registries aligned with product portfolios.
  • Business support for product registration and post-market compliance activities.
  • Review promotional activities and artwork/packaging materials for compliance.

Candidate Criteria:

  • Experience: Knowledge of all aspects of medical device regulatory compliance.
  • Develop broad understanding of technical, manufacturing, sales, and marketing functions.
  • Establish network with internal and external stakeholders.
  • Proficiency in various Microsoft software.
  • Excellent attention to detail and communication skills.
  • Strong interpersonal skills, particularly in facilitating and influencing.
  • Ability to prioritize business priorities using organizational and planning skills.
  • Essential: Graduate qualifications in science.
  • Desirable: Background in health sciences or business.

How to Apply:

If interested, click 'APPLY' or contact Prasanth Natesan, Recruitment Consultant at ekta.ojha@persolkelly.com.au for a confidential discussion.

About PERSOLKELLY:

PERSOLKELLY prioritizes supporting careers by offering expertise and capability. We strive for a safe and inclusive environment, welcoming individuals from diverse backgrounds to apply. Visit our website for more information. Follow our LinkedIn page for updates and insights.