Werfenlife SA.
Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device IVD Experi
Werfenlife SA., Los Angeles, California, United States
Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device IVD Experience
Country United States Shift 1st About the Position
Introduction
Werfen 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. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. 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. Overview
Job Summary Autoimmunity Manager responsibilities include planning and managing the operations of the 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. Accountable for meeting department goals and budgets, and for implementing and improving processes, procedures and policies that enable optimum performance of people and resources. Manages direct and indirect reports, including individual contributors and people managers, following SOPs, Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies. As a member of the Werfen management team, models Werfen Values and Manager competencies and expectations. Within the Regulatory Affairs Team, the Regulatory Affairs Manager is responsible for developing regulatory plans, preparing regulatory submissions (e.g., 510(k), EU IVDR Technical Documentation), managing communications with Regulatory Agencies (FDA, EU Notified Bodies, Health Canada, etc.), and for on-market products overseeing regulatory market authorization impact assessments for changes and associated submissions in marketed regions. This role oversees and assists in the review of promotional materials to ensure regulatory compliance, champions continuous improvement, leads department initiatives, and manages the regulatory intelligence program in collaboration with internal and external stakeholders, supporting global regulatory compliance for Werfen IVD products. Responsibilities
Key Accountabilities Teamwork: Coordinate with department leadership and cross-functional areas (R&D, Project Management, Marketing, Quality Engineering, Manufacturing, Quality Assurance) to establish priorities and goals for design and development projects, product changes, international registrations, and advertising materials. Model effective team collaboration. New Product Development Support: Develop regulatory plans and oversee implementation for introducing new products across geographies (US, EU, Canada, Australia, Japan, China, etc.). Oversee and assist in preparing and submitting regulatory submissions (510(k)s, Pre-submissions, IVDR Technical Documentation). Manage communications with Regulatory Agencies during development and review; align product development plans with regulatory expectations; ensure timely submissions and maintain documentation in internal repositories. On-Market Support (Sustaining): Lead regulatory impact assessments of changes to existing Market Authorizations; oversee submissions for product changes; review and approve labeling, scientific papers, customer communications, and promotional materials for regulatory compliance. Regulatory Intelligence: Monitor global regulatory developments, maintain knowledge of applicable requirements, participate in trade organizations, analyze new regulations, and communicate impact to senior management. Department Management: Set priorities, educate and broaden regulatory knowledge, author and maintain procedures, support regulatory inspections and audits, and provide back-up support for the Regulatory Team. Team Management: Responsible for department performance, hiring, development, and budget; foster accountability, collaboration, and compliance; manage employee relations and performance management; may include managing people managers. Networking/Key Relationships R&D Teams Project Management Marketing Quality Engineering Manufacturing Global Werfen RA/QA Personnel and Regional Partners Product Testing Post-market compliance 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 Management may substitute relevant work experience for a degree and/or adjust experience requirements as needed. Experience: Minimum 8 years of Regulatory Affairs experience, with at least 5 years in IVD Regulatory Affairs. Minimum 5 years managing regulatory professionals, including staffing, development, budget management, and policy adherence. Proven success obtaining regulatory approvals in major geographies (US, EU under IVDR, etc.). Hands-on experience preparing regulatory submissions (510(k), IVDR) and managing relationships with regulatory agencies (FDA, EU Notified Bodies, etc.). Experience coordinating with cross-functional stakeholders. Experience with scientific writing and communications. Skills & Capabilities Solid knowledge of regulatory requirements for US, EU (IVDR), Canada, and Australia approvals. Working knowledge of Asia Pacific, Latin America, and Middle East regulatory requirements. Strong understanding of IVD product development, analytical/clinical validation (CLSI guidelines preferred). Ability to interpret complex scientific topics for regulatory strategy and intelligence. Excellent verbal/written communication and scientific writing/presentation skills. Mentoring and development of staff; ability to manage direct reports and cross-functional teams. Leadership, influence, and negotiation skills; cross-functional project leadership in dynamic environments. Proactive problem solving and ability to handle ambiguity; multitasking in fast-paced settings. Advanced MS Office skills and electronic publishing/file management. Location / Office Must reside in the San Diego area Must be present in the office Mon – Friday Supervisory Experience Prior experience managing direct reports is required Other The statements describe general nature and level of work and are not intended to be exhaustive. Duties may change with or without notice. This description does not constitute a contract or alter the at-will employment relationship. This role may include travel as needed. Compensation The salary range for this position is currently $130,000 - $190,000 annually. Individual compensation is based on qualifications, experience, skills, and internal/external factors. Equal Opportunity Werfen is an Equal Opportunity employer and is committed to a diverse workplace. We prohibit unlawful discrimination, harassment, or retaliation on the basis of race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable law. If you require accommodation in the online application process, please contact talentacquisition@werfen.com. We operate in over 30 countries and more than 100 territories through distributors, with annual revenue around $2 billion and more than 7,000 employees worldwide.
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Country United States Shift 1st About the Position
Introduction
Werfen 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. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. 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. Overview
Job Summary Autoimmunity Manager responsibilities include planning and managing the operations of the 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. Accountable for meeting department goals and budgets, and for implementing and improving processes, procedures and policies that enable optimum performance of people and resources. Manages direct and indirect reports, including individual contributors and people managers, following SOPs, Quality Management Systems regulations, Human Resources, Environment, Health and Safety, and other company policies. As a member of the Werfen management team, models Werfen Values and Manager competencies and expectations. Within the Regulatory Affairs Team, the Regulatory Affairs Manager is responsible for developing regulatory plans, preparing regulatory submissions (e.g., 510(k), EU IVDR Technical Documentation), managing communications with Regulatory Agencies (FDA, EU Notified Bodies, Health Canada, etc.), and for on-market products overseeing regulatory market authorization impact assessments for changes and associated submissions in marketed regions. This role oversees and assists in the review of promotional materials to ensure regulatory compliance, champions continuous improvement, leads department initiatives, and manages the regulatory intelligence program in collaboration with internal and external stakeholders, supporting global regulatory compliance for Werfen IVD products. Responsibilities
Key Accountabilities Teamwork: Coordinate with department leadership and cross-functional areas (R&D, Project Management, Marketing, Quality Engineering, Manufacturing, Quality Assurance) to establish priorities and goals for design and development projects, product changes, international registrations, and advertising materials. Model effective team collaboration. New Product Development Support: Develop regulatory plans and oversee implementation for introducing new products across geographies (US, EU, Canada, Australia, Japan, China, etc.). Oversee and assist in preparing and submitting regulatory submissions (510(k)s, Pre-submissions, IVDR Technical Documentation). Manage communications with Regulatory Agencies during development and review; align product development plans with regulatory expectations; ensure timely submissions and maintain documentation in internal repositories. On-Market Support (Sustaining): Lead regulatory impact assessments of changes to existing Market Authorizations; oversee submissions for product changes; review and approve labeling, scientific papers, customer communications, and promotional materials for regulatory compliance. Regulatory Intelligence: Monitor global regulatory developments, maintain knowledge of applicable requirements, participate in trade organizations, analyze new regulations, and communicate impact to senior management. Department Management: Set priorities, educate and broaden regulatory knowledge, author and maintain procedures, support regulatory inspections and audits, and provide back-up support for the Regulatory Team. Team Management: Responsible for department performance, hiring, development, and budget; foster accountability, collaboration, and compliance; manage employee relations and performance management; may include managing people managers. Networking/Key Relationships R&D Teams Project Management Marketing Quality Engineering Manufacturing Global Werfen RA/QA Personnel and Regional Partners Product Testing Post-market compliance 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 Management may substitute relevant work experience for a degree and/or adjust experience requirements as needed. Experience: Minimum 8 years of Regulatory Affairs experience, with at least 5 years in IVD Regulatory Affairs. Minimum 5 years managing regulatory professionals, including staffing, development, budget management, and policy adherence. Proven success obtaining regulatory approvals in major geographies (US, EU under IVDR, etc.). Hands-on experience preparing regulatory submissions (510(k), IVDR) and managing relationships with regulatory agencies (FDA, EU Notified Bodies, etc.). Experience coordinating with cross-functional stakeholders. Experience with scientific writing and communications. Skills & Capabilities Solid knowledge of regulatory requirements for US, EU (IVDR), Canada, and Australia approvals. Working knowledge of Asia Pacific, Latin America, and Middle East regulatory requirements. Strong understanding of IVD product development, analytical/clinical validation (CLSI guidelines preferred). Ability to interpret complex scientific topics for regulatory strategy and intelligence. Excellent verbal/written communication and scientific writing/presentation skills. Mentoring and development of staff; ability to manage direct reports and cross-functional teams. Leadership, influence, and negotiation skills; cross-functional project leadership in dynamic environments. Proactive problem solving and ability to handle ambiguity; multitasking in fast-paced settings. Advanced MS Office skills and electronic publishing/file management. Location / Office Must reside in the San Diego area Must be present in the office Mon – Friday Supervisory Experience Prior experience managing direct reports is required Other The statements describe general nature and level of work and are not intended to be exhaustive. Duties may change with or without notice. This description does not constitute a contract or alter the at-will employment relationship. This role may include travel as needed. Compensation The salary range for this position is currently $130,000 - $190,000 annually. Individual compensation is based on qualifications, experience, skills, and internal/external factors. Equal Opportunity Werfen is an Equal Opportunity employer and is committed to a diverse workplace. We prohibit unlawful discrimination, harassment, or retaliation on the basis of race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable law. If you require accommodation in the online application process, please contact talentacquisition@werfen.com. We operate in over 30 countries and more than 100 territories through distributors, with annual revenue around $2 billion and more than 7,000 employees worldwide.
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