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Sr. Regulatory Affairs Specialist - Remote

  • Location: Atlanta, GA, 30354
  • Job Type:Contract

Posted 21 days ago

Terrific Contract Opportunity with a FULL suite of benefits!

Position: Sr. Regulatory Affairs Specialist IV
Location: REMOTE
Term: 8 months

Day-to-Day Responsibilities:

  • Accountable to ensure all elements of Global Regulatory Affairs are considered during the Supply Chain Digital Transformation requirement gathering, system design, and implementation.
  • Ensures existing regulatory affairs system interfaces are identified and designed appropriately into the new solution(s). Consider global activities and requirements.
  • Liaison with the global regulatory affairs team to ensure current standards are well understood and integrated into the duration of Digital Transformation.
  • Develops standardized system approaches aligned with industry best practices in regulatory affairs.
  • Supports the creation of systems and tools to add global efficiency and data sharing as a result of the Digital Transformation.
  • Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
  • Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.

Is this a good fit? (Requirements):

  • A Bachelors degree in Sciences, Engineering, or equivalent degree.
  • 8+ years of experience in a regulatory affairs role in a medical device, pharmaceutical, cosmetic or similar environment.
  • Proven ability to communicate in written and spoken English.
Desired Skills:
  • A minimum of 5 years developing and deploying, efficient and effective regulatory affairs processes and automation, preferably across multiple geographic regions.
  • Experience in an organization with regulatory affairs as a compliance function. Experience with company controls for global regulatory submissions and associated data. Experience with a Regulatory Information Management system (RIM) and Document management System required.
  • Demonstrated understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe.
  • Thorough understanding and experience interfacing with regulatory bodies across all regions.
  • Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies. Gather and articulate global requirements.
  • Understanding of key regulations and standards applicable specifically related to medical devices as a consumer product or other highly regulated products.
  • Is able to influence and engage at varying levels of the organization.
  • Training system development and/or management
  • Experience working in quality systems where these regulations and guidelines are followed.
  • Understands and can apply industry-standard practices such as Good Manufacturing (GMP)
  • Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
  • Collaborative, responsive, action-oriented and innovative problem solver.
Apply to MATRIX today!