Staff Regulatory Specialist

3 weeks ago


San Diego, United States Werfen Full time

**Job Overview**:

- Post Date
- May 23, 2024
- Number
- ICIMS-2023-6590
- Job Function
- QA&RA
- Location
- San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States
- Country
- United States
- Shift
- 1st

**About the Position**:
**Overview**:
**Werfen**

***

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

**Position Summary**:
The Staff Regulatory Specialist performs product registrations and act as the company representative with the applicable regulatory authorities. The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. Additionally, the position develops Regulatory strategies for new product development and design changes while representing regulatory interest on product development teams. The Staff Regulatory Specialist advises on the implementation of compliance mechanisms for new and emerging regulations, standards, and regulatory guidances. This position collaborates with personnel with the business unit and company.

**Responsibilities**:
**Key Accountabilities**
- ** Design Control**: Is Regulatory lead on cross-functional product development teams. Provide team with strategic and tactical guidance regarding global regulatory requirements to support product marketing authorizations. Review product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
- ** Regulatory Projects**: Independently lead multiple long-term projects. Interact with supervisor as required on activities, issues, or turning points. Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
- ** Regulatory Intelligence**: Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies. Monitor and analyze the development of new and emerging regulations, guidance, and standards in marketed geographies. Coordinate evaluation of new and emerging standards with Subject Matter Experts. Assist in the development of plans for meeting and complying with new regulations, guidance, and standards. Develop strategy for complying with new and emerging regulations, guidance, and standards.
- **Regulatory Strategic and Tactical Management**: Assist Regulatory management with development of strategic and tactical options for accomplishing company goals and initiatives. Implement regulatory strategies and tactics. Manage regulatory consultants when engaged to assist with goals.
- ** Labeling, Advertising, and Promotion Review**:Review and approve labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc. Provide regulatory review and approval for product marketing colletrial.
- ** Quality Management System Support**: Assist in the education and broadening the regulatory knowledge within the Werfen teams. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Regulatory processes. Support Regulatory function and assist other departments in audit and inspection preparation.
- Comply with all aplicable standard operating procedures (SOPs), QSR regulations, as well as aplicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
- Comply with all aplicable standard operating procedures (SOPs), QSR regulations, as well as aplicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
- Reflect Werfen Values in the quality of work and in working relations



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