Terrific Contract Opportunity with a FULL suite of benefits!
Position: Sr. Regulatory Affairs Specialist IV
Term: 8 months
- 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.
- 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.