Manager/ Sr. Manager, Regulatory Affairs

Werfenlife SA.; San Diego (CA); Vor Ort; USD 130 000 - 190 000; Vollzeit

Zusammenfassung

An established industry player seeks a Regulatory Affairs Manager to lead a team in ensuring compliance with regulatory standards for innovative diagnostic products. This role involves developing regulatory strategies, managing submissions, and collaborating with various departments to support product launches. The ideal candidate will have extensive experience in regulatory affairs, particularly in IVD, and a strong track record of obtaining approvals in major markets. Join a company committed to quality and innovation in diagnostics, where your expertise will play a vital role in improving patient care and outcomes.

Qualifikationen

• 8+ years in Regulatory Affairs, with 5+ years in IVD Regulatory Affairs.
• Strong knowledge of regulatory approvals and IVD product development.

Aufgaben

• Manage regulatory plans and submissions for IVD products.
• Coordinate with cross-functional teams for new product development.

Kenntnisse

Regulatory Requirements Knowledge

IVD Product Development

Verbal Communication

Written Communication

Ausbildung

Bachelor’s degree in bioengineering/biomedical engineering

Advanced degree preferred

Regulatory Affairs Certification

Jobbeschreibung

Manager/ Sr. Manager, Regulatory Affairs

Country: United States

Shift: 1st

About the Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

Overview

Job Summary

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures, and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers.

Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for managing a team of technical staff to develop regulatory plans for products, to prepare regulatory submissions such as 510(k), EU IVDR Technical Documentation, etc., and manage communications with Regulatory Agencies e.g. FDA, EU Notified Bodies, Health Canada, etc. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion. This role will also be responsible for managing the regulatory intelligence program in collaboration with internal and external stakeholders and supporting initiatives for global regulatory compliance for Werfen invitro diagnostic (IVD) products.

Responsibilities

Key Accountabilities

• Teamwork: Coordinate with department leadership and other cross-functional areas including R&D, Project Management, Marketing, Quality Engineering, Manufacturing, and Quality Assurance.
• New Product Development Support: Assist the Regulatory Affairs team in developing regulatory plans and oversee implementation for introducing new products in various geographies.
• On-Market Support (Sustaining): Provide leadership and guidance in the regulatory impact assessments of changes on existing Market Authorizations.
• Regulatory Intelligence: Oversee and perform ongoing surveillance of new and revised regulatory requirements globally.
• Department Management: Establish and monitor priorities and goals for the Regulatory Affairs team.
• Team Management: Responsible for overall performance of department operations, personnel, and budget.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

Education:

• Bachelor’s degree in bioengineering/biomedical engineering, biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.
• Regulatory Affairs Certification preferred.

Experience:

• Minimum 8 years of experience in Regulatory Affairs, with at least 5 years in IVD Regulatory Affairs.
• Minimum 5 years of experience in managing regulatory professionals.
• Demonstrated success in obtaining regulatory approvals in major geographies.

Skills & Capabilities:

• Strong knowledge of regulatory requirements for obtaining Regulatory Approvals.
• Strong knowledge of IVD product development process.
• Strong skills in verbal and written communication.

Travel Requirements:

Approximately <10% of time.

The salary range for this position is currently $130,000- $190,000 annual. Individual compensation is based on the candidate’s qualifications for the position.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace.