Regulatory Affairs Specialist in Lagos, Nigeria

at CHIVAN RESOURCE

Industry
Packaging and Containers
Specialization
Marketing / Advertising / Branding
Minimum Qualification
HND
Required Experience
1 - 3 years
Employment Type
Contract
Gender
Male or Female

Job Description

Job Description

  • Responsible for assisting the team with regulatory filings as necessary to market company products.
  • This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
  • Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
  • Respond to requests from foreign government and/or distributors as needed
  • Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
  • Evaluate risk of proposed regulatory strategies; may offer solutions
  • Reviews proposed labeling for compliance with applicable global regulations
  • Writes and manages the development of package inserts
  • Reviews and evaluates promotion and advertising material for compliance with applicable regulations
  • Reviews proposed product changes for impact on regulatory status of the product
  • Communicates with regulatory and governmental agencies with supervision
 

Responsibilities

 

  • Responsible for assisting the team with regulatory filings as necessary to market company products.
  • This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
  • Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
  • Respond to requests from foreign government and/or distributors as needed
  • Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
  • Evaluate risk of proposed regulatory strategies; may offer solutions
  • Reviews proposed labeling for compliance with applicable global regulations
  • Writes and manages the development of package inserts
  • Reviews and evaluates promotion and advertising material for compliance with applicable regulations
  • Reviews proposed product changes for impact on regulatory status of the product
  • Communicates with regulatory and governmental agencies with supervision
 

Requirements

Candidate Requirements

    Bachelor's Degree required; concentration in Life Sciences, Technical/Engineering or related field, preferred
    A minimum of 2 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
    Regulatory Affairs Certification
    A combination of education and experience may be considered.
    Strong writing, communication, and interpersonal skills
    Strong attention to detail; ability to multi-task and balance competing priorities
    Knowledge of overall business environment and the marketplace
    Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed based on functional area
    Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
    Ability to identify risk in Regulatory strategies
    Strong problem solving skills
    Effective negotiating skills
    Basic computer skills, including Microsoft Office Suite

  Apply Now

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