Regulatory Affairs (Clinical)

Regulatory Affairs (Clinical)
  • Competitive
    HOUR
  • Temporary
  • Remote US, US Remote Remote US Remote
Job Ref: JO000115859
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 20 April 2021


SRG is a Global Life Sciences staffing and consulting firm and we are seeking a Regulatory Affairs Specialist for a 7 month contract. This is a remote position.

ESSENTIAL ACCOUNTABILITIES:

• 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.

• 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.

QUALIFICATIONS

Basic Qualifications

• A Bachelor’s 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.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
18/05/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kayla Sanford

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