Regulatory Affairs Operations Specialist – Vascular

Required Qualifications

• Bachelor’s degree (or equivalent) in scientific discipline, engineering, or medical fields
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharmaceuticals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, regulatory compliance, or related area. Note: Higher education may compensate for years of experience.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

What You’ll Work On

1. 1Assess and communicate impacts of evolving new regulations on internal quality system processes, regulatory submissions, and regulatory operational practices; ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
2. 2Serve as a subject matter expert for International Addendum Labeling requirements and controls, partnering with Shared Services, International Regulatory Affairs, Labeling, Commercial Quality, and Regulatory Affairs to ensure requirements are reflected within the quality system, and business compliance with country-specific requirements.
3. 3Manage execution of the Audit Readiness Program for Regulatory Affairs including preparation of pre-audit requests and in-audit requests, audit resource management, audit calendar and KPI management, and audit risk mitigation activities such as audit near misses / opportunities to closure, audit storyboards for critical topics; partner with Regulatory Compliance, Regulatory Affairs, Quality, Shared Services as needed for audits.
4. 4Maintain key pre-audit requests up to date throughout the year and ensure that key audit activities are disseminated to appropriate personnel.
5. 5Support audit backrooms, or front rooms as applicable.
6. 6Prepare and / or review Regulatory Affairs formal management review and internal metrics content.
7. 7Maintain processes and SOPs current, in alignment with new regulatory requirements.  Creates, reviews, and processes, including approving change orders in the applicable document control systems.
8. 8Assist in the development of quality system conformance strategy and update strategy based upon Emerging Issues/ Regulatory Intelligence.
9. 9Acts as a regulatory operations representative on cross-functional project teams and task forces, communicates regulatory requirements and impact of regulations to the functional team(s).  Provides guidance and expertise.
10. 10Investigate nonconformities and determine mitigations, resolution plan (CAPA)
11. 11Delivers on project timelines to achieve departmental and organizational objectives.
12. 12Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
13. 13Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.