Werfenlife SA.
Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device
Werfenlife SA., San Diego, California, United States, 92189
Autoimmunity Manager/ Sr. Manager, Regulatory Affairs- Medical Device
Country United States Shift 1st 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. They are responsible for ensuring department goals are met and budgets are managed, implementing and improving processes, procedures and policies, and leading the work of direct and indirect reports in accordance with SOPs, Quality Management Systems regulations, HR, and other policies. As a member of the Werfen management team, they model Werfen Values and Manager competencies and expectations. Within the Regulatory Affairs Team, the Regulatory Affairs Manager will lead the team to develop regulatory plans for products, prepare regulatory submissions (e.g., 510(k), EU IVDR Technical Documentation), manage communications with Regulatory Agencies (FDA, EU Notified Bodies, Health Canada, etc.), perform regulatory market authorization impact assessments for product changes, and oversee review of promotional materials to ensure compliance. The role champions continuous improvement and leads department initiatives, manages the regulatory intelligence program, and supports 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, QA) to set priorities and goals; model effective team collaboration. New Product Development Support: Assist with regulatory plans for new products across geographies (US, EU, Canada, Australia, Japan, China, etc.); oversee regulatory submissions (510(k), Pre-submissions, IVDR Technical Documentation); manage communications with Regulatory Agencies; align development plans with regulatory expectations for approvals; ensure timely submissions and maintain submission materials in internal repositories. On-Market Support (Sustaining): Lead regulatory impact assessments for changes to existing market authorizations (design, composition, manufacturing, labeling); oversee submissions for product changes; review labeling, scientific papers, customer communications, and promotional materials for regulatory compliance. Regulatory Intelligence: Monitor global regulatory developments, maintain current knowledge, participate in professional organizations, analyze new regulations, and communicate impact to senior management. Department Management: Set priorities and goals; educate and broaden regulatory knowledge; author and maintain procedures and templates; support regulatory inspections and audits; provide back-up support for the Regulatory Team. Team Management: Oversee department performance, hiring, development, budgeting, and compliance; foster accountability, teamwork, and continuous improvement; manage employee relations and coordinate with HR as needed; 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 has the discretion to substitute relevant work experience for a degree and/or adjust years of experience requirements. Experience Minimum 8 years in Regulatory Affairs, with at least 5 years in IVD Regulatory Affairs. Minimum 5 years of experience managing regulatory professionals, including staffing, development, budgeting, and adherence to procedures and regulations. Proven success obtaining regulatory approvals in major geographies (US, EU IVDR, others). Hands-on experience preparing regulatory submissions (510(k), IVDR) and managing relationships with agencies (FDA, EU Notified Bodies). Experience managing cross-functional stakeholder relationships; experience with scientific writing and communications. Skills & Capabilities Strong knowledge of regulatory requirements for US, EU IVDR, Canada, and Australia. Working knowledge of global regulatory requirements in Asia Pacific, Latin America, and Middle East. Deep understanding of the IVD product development process and analytical/clinical validation (CLSI guidelines preferred). Ability to interpret complex scientific topics for regulatory strategy and policy; excellent written and verbal communication; mentoring and staff development capabilities. Leadership, influence, negotiation, collaboration, and ability to work in a fast-paced environment with ambiguity. Proficiency in Microsoft Office Suite and electronic publishing/file management systems. 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 Information
The physical demands described here are representative of those that must be met to perform the essential functions. Regular communication, data review, and use of lab equipment are required. May include standing/walking up to 8 hours per day or sitting up to 8 hours per day. May involve lifting up to 25 pounds. The noise level is usually moderate. The salary range is currently $130,000-$190,000 annually. Compensation is based on qualifications, experience, and internal factors. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen prohibits unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you require an accommodation in the online application process, please contact NA talentacquisition@werfen.com for assistance. We operate in over 30 countries and in 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 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. They are responsible for ensuring department goals are met and budgets are managed, implementing and improving processes, procedures and policies, and leading the work of direct and indirect reports in accordance with SOPs, Quality Management Systems regulations, HR, and other policies. As a member of the Werfen management team, they model Werfen Values and Manager competencies and expectations. Within the Regulatory Affairs Team, the Regulatory Affairs Manager will lead the team to develop regulatory plans for products, prepare regulatory submissions (e.g., 510(k), EU IVDR Technical Documentation), manage communications with Regulatory Agencies (FDA, EU Notified Bodies, Health Canada, etc.), perform regulatory market authorization impact assessments for product changes, and oversee review of promotional materials to ensure compliance. The role champions continuous improvement and leads department initiatives, manages the regulatory intelligence program, and supports 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, QA) to set priorities and goals; model effective team collaboration. New Product Development Support: Assist with regulatory plans for new products across geographies (US, EU, Canada, Australia, Japan, China, etc.); oversee regulatory submissions (510(k), Pre-submissions, IVDR Technical Documentation); manage communications with Regulatory Agencies; align development plans with regulatory expectations for approvals; ensure timely submissions and maintain submission materials in internal repositories. On-Market Support (Sustaining): Lead regulatory impact assessments for changes to existing market authorizations (design, composition, manufacturing, labeling); oversee submissions for product changes; review labeling, scientific papers, customer communications, and promotional materials for regulatory compliance. Regulatory Intelligence: Monitor global regulatory developments, maintain current knowledge, participate in professional organizations, analyze new regulations, and communicate impact to senior management. Department Management: Set priorities and goals; educate and broaden regulatory knowledge; author and maintain procedures and templates; support regulatory inspections and audits; provide back-up support for the Regulatory Team. Team Management: Oversee department performance, hiring, development, budgeting, and compliance; foster accountability, teamwork, and continuous improvement; manage employee relations and coordinate with HR as needed; 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 has the discretion to substitute relevant work experience for a degree and/or adjust years of experience requirements. Experience Minimum 8 years in Regulatory Affairs, with at least 5 years in IVD Regulatory Affairs. Minimum 5 years of experience managing regulatory professionals, including staffing, development, budgeting, and adherence to procedures and regulations. Proven success obtaining regulatory approvals in major geographies (US, EU IVDR, others). Hands-on experience preparing regulatory submissions (510(k), IVDR) and managing relationships with agencies (FDA, EU Notified Bodies). Experience managing cross-functional stakeholder relationships; experience with scientific writing and communications. Skills & Capabilities Strong knowledge of regulatory requirements for US, EU IVDR, Canada, and Australia. Working knowledge of global regulatory requirements in Asia Pacific, Latin America, and Middle East. Deep understanding of the IVD product development process and analytical/clinical validation (CLSI guidelines preferred). Ability to interpret complex scientific topics for regulatory strategy and policy; excellent written and verbal communication; mentoring and staff development capabilities. Leadership, influence, negotiation, collaboration, and ability to work in a fast-paced environment with ambiguity. Proficiency in Microsoft Office Suite and electronic publishing/file management systems. 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 Information
The physical demands described here are representative of those that must be met to perform the essential functions. Regular communication, data review, and use of lab equipment are required. May include standing/walking up to 8 hours per day or sitting up to 8 hours per day. May involve lifting up to 25 pounds. The noise level is usually moderate. The salary range is currently $130,000-$190,000 annually. Compensation is based on qualifications, experience, and internal factors. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen prohibits unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you require an accommodation in the online application process, please contact NA talentacquisition@werfen.com for assistance. We operate in over 30 countries and in more than 100 territories through distributors, with annual revenue around $2 billion and more than 7,000 employees worldwide.
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