- Function: Business / Systems Analysts
- Job Ref: 236333
• Accountable to ensure all elements of Global Regulatory Affairs are considered during the Supply Chain Digital Transformation requirement gathering, system design, and implementation.
• Provide project leadership, expertise and counsel that result in the development, implementation, standardization, and improvement of processes and implementation of corresponding software/systems/solutions.
• Support the design, development and implementation of lifecycle and change control business processes across global systems and functions to facilitate operational execution.
• 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.
• Assist with the global rollout, development, and support of Enterprise regulatory information and document management processes and tools, including EtQ Reliance.
• Lead and assist in the development of strategies and projects that improve business practices, and assure business, facility and corporate objectives and regulatory compliance requirements are met.
• Recommend, develop, and support implementation of regulatory policies, procedures, and systems.
GENERAL EXPECTATIONS AND ACCOUNTABILITIES
• Manage self in accordance with the expected behaviors.
• Influence and recommend new quality 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 quality 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 their 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 QRC business 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 QMS 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.
• A Bachelor’s degree in Sciences, Engineering, or equivalent degree.
• 3+ years of experience in role in a regulated industry such as medical device, pharmaceutical, cosmetic, or similar environment.
• Proven ability to communicate in written and spoken English.
• A minimum of 3 years developing and deploying, efficient and effective software implementation programs which may include regulatory affairs processes and automation, preferably across multiple geographic regions.
• 3-5 years of Project management / agile method experience is desirable.
• Ability to provide functional expertise for the creation of document management workflows and broader enterprise system environment
• 5+ years’ experience with a focus on new digital process and/or product data management systems
• Project management training or certificate helpful. Ability to communicate complex plans and requirements and drive team to action.
• Experience in an organization with regulatory affairs as a compliance function. Experience with company controls for regulatory submissions and associated data.
• Experience with a ETQ and Regulatory Information Management system (RIM) and document management system(s) required.
• Track record of project delivery success that should include: System Implementation / Integration, cost savings, process improvement
• Keen technical skills and demonstrable ability to assess needs, identify issues, recommend alternatives, and implement and lead change
• Strong analytical skills, demonstrated organizational and leadership skills, examples of effective teamwork, a track record of consistently meeting deadlines and due dates
• Six-Sigma, Continuous Improvement, is preferred along with a proven track record of cost savings and continuous improvement accomplishments
• Demonstrated understanding of regulated products Such as Medical Devices, Consumer Products, and Cosmetic regulations across the globe.
• General understanding and experience interfacing with regulatory bodies across all regions.
• Demonstrate understanding and impact of industry trends and best practices via internal/external benchmarking for integration considerations into business specific digital strategies. Gather and articulate global requirements, as applicable.
• General understanding the application of regulations and standards applicable to medical devices as a consumer product or other highly regulated products.
• Is able to influence and engage at varying levels of the organization to deliver projects to plan.
• 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. Getting work done through others to achieve desired outcomes.
• Collaborative, responsive, action-oriented, and innovative problem solver.
Apply to MATRIX today!
Candidates will be responsible for following the client's COVID-19 protocols. Please refer to your MATRIX representative for specifics.
At MATRIX, we expertly match talented professionals with job opportunities to elevate careers. Since 1983, we have placed thousands of professionals at innovative clients across every industry ranging from small startups to Fortune 50 companies. It’s why we’re consistently in the top 25 of all U.S. IT staffing firms and why our consultants rate us well above the industry average, earning us ClearlyRated's Best of Staffing awards year after year. People come to us for a job, and stay with us because of our top-notch consultant care.
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For hourly W2 contract roles MATRIX offers a highly competitive benefit package including Medical, Dental, Vision, Life, Disability, HSA, and 401(k) with pre and post-tax options. Please see MatrixRes.com/Benefits for more information.
For direct hire placement with our clients, benefits would be offered in accordance with that particular client’s offerings. This may include PTO, Medical, Dental, Vision, 401K and other pre and post-tax options.