Job Details

ID #12358999
State Wisconsin
City Madison
Job type Permanent
Salary USD TBD TBD
Source Genesis10
Showed 2021-04-18
Date 2021-04-17
Deadline 2021-06-16
Category Architect/engineer/CAD
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Sr. Regulatory Affairs Specialist IV

Wisconsin, Madison, 53701 Madison USA

Vacancy expired!

Genesis10 is currently seeking a Sr. Regulatory Affairs Specialist for a remote 8 month + contract position.

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.

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.
  • Proven ability to communicate in written and spoken English.
  • Able to work as a W2 employee of Genesis10 (no corp to corp)

Preferred Qualifications:
  • 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 to Company 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.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

About Genesis10: Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at www.genesis10.com "Genesis10 is an Equal Opportunity Employer, M/F/D/V

Vacancy expired!

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