Systems Analyst II

Job Summary

We are looking for individual to join our client’s team as Systems Analyst II. The Regulatory System Analyst brings subject matter expertise, regulatory experience, and best practice knowledge to lead the technical development and implementation of specific areas of Global Regulatory Affairs (GRA) processes and associated IT systems. Provides partnership, direction, and guidance to the business community to ensure that goals are met through the effective provision of advanced technology solutions and services. Provides oversight and guidance to enable the successful delivery of an end-to-end Digital Transformation.

Job Description

• Accountable to ensure all elements of Global Regulatory Affairs are considered during the Digital Transformation requirement gathering, system design, and implementation.
• Ensures existing regulatory affairs system interfaces are identified and designed appropriately into the new solution(s) with the consideration of GRA activities and requirements.
• Liaison with the GRA team to ensure current standards are well understood and integrated into the end-to-end 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 because of the digital transformation objectives.
• General understanding of applicable regulatory requirements for regions.
• Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential risk & impact to the enterprise.
• Manage self in accordance with the expected One Company Behaviors.
• Influence and recommend new GRA concepts, tools, and strategies for the enterprise quality organization.
• Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in RA management systems, processes, and regulations.
• Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.
• Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
• Conduct all communications and transactions with the utmost integrity, consistent with the Company Code of Conduct. Communicate effectively with Senior Leaders, Peers, Functional Partners.
• Provide strategic thought leadership for the build and management of complex, end-to-end GRA process solutions to help drive compliance across digital systems with wide range of complexity.
• Experience working with blended teams consisting of employees, vendors, and consultants with both onshore and offshore resources.
• Excellent written and verbal communication skills along with strong desire to work in cross functional teams.
• Possess strong leadership skills and exhibit creative thinking to be able to come up with inventive solutions to solve business challenges.
• Provide thought leadership while keeping up with industry trends and disseminating information across the organization.
• Familiar with the technology landscape for end-to-end Product Lifecycle and where the RA elements fit along that path.
• Ability to work in a virtual team which may work across distance (remote), cultures and time zones, in a matrix with multiple reporting lines, and may extend outside the organization including suppliers, partners and customers.

Skills Required

• 5 years of experience in an analyst role supporting a regulated environment in a medical device, pharmaceutical, cosmetic, or similar environment.
• Proven ability to communicate in written and spoken English.

Preferred Qualifications:

• A minimum of 5 years developing and deploying, efficient and effective IT 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 systems (RIMs) and Document management Systems required such as ETQ and MRP such asSAP etc.
• Experience with global databases.
• General understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe.
• Demonstrate understanding and impact of compliance industry trends, emerging regulatory compliance requirements for considerations into business specific strategies.
• General understanding of key regulations and standards applicable to Company specifically related to medical devices, consumer products, or other highly regulated products.
• 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) and Good Documentation Practices (GDP).
• 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.

Education/Training/Certifications

• A Bachelor’s degree in Sciences, Systems Engineering, or equivalent degree.

Additional Requirements

• Position is 100% remote.
• Position is systems oriented with experience in Compliance/ Regulatory.
• Looking for candidates who have experience with: SAP/ ERP, document management, etc.

Job Types: Full-time, Contract

Salary: $30.00 - $40.00 per hour

Ability to commute/relocate:

• Neenah, WI 54956: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: One location

Salary : $30 - $40