Werfen
About the Position
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 The Senior Post Market Compliance Specialist will ensure compliance for on‑market devices with post‑market global regulations for post‑market surveillance, reportable events, vigilance, and field actions. The position will lead cross‑functional teams in post‑market assessments and execution of surveillance, reportability, vigilance, and field actions. The Specialist will represent the company in interactions and communications with regulatory authorities and notified bodies on post‑market reporting.
Responsibilities
Field Actions:
Perform assessments to determine whether an issue requires a field action in impacted geographies. Coordinate internal actions, work directly with relevant agencies, manage field action activities, author Health Hazard Evaluation reports, draft and send notifications, and author field action reports to relevant agencies. Compile and review assessments and execution records to ensure compliance with AID procedures and relevant regulations. Represent the company in post‑market regulatory communications.
Post‑Market Surveillance Program:
Act as subject‑matter expert on global post‑market surveillance requirements. Analyze inputs, create PMS review schedules, adjust as needed, research and analyze regulatory data, lead cross‑functional teams in gathering, analyzing post‑market data, evaluating trends, forming action items, and compiling reports. Ensure transfer of action items into CAPA and Design Control systems and maintain PMS documentation records.
Reportable Events:
Lead and coordinate timely investigations into all potentially reportable incidents, adverse events, and device malfunctions related to Autoimmunity medical devices. Document investigations, decisions and submit mandatory reports to global regulatory agencies. Maintain event records.
Quality Management System Support:
Educate and broaden regulatory knowledge within Werfen teams, benchmark processes, author and maintain departmental procedures and templates, support post‑market function, assist other QRC departments in audit and inspection preparation, and summarize post‑market data for Management Review Meetings.
Comply with all applicable SOPs, QMS regulations, EHS, Human Resources and other policies.
Reflect Werfen values in quality of work and working relationships.
Networking/Key Relationships:
Manufacturing teams
QA, QE, QPS, and Regulatory teams
R&D teams including Manufacturing Technical Support
Marketing and Commercial Teams
Contract manufacturers and suppliers
Senior and Executive Management
Affiliates
Other Werfen departments and staff
Regulatory Agencies (Domestic and International)
Qualifications Minimum Knowledge & Experience Required
Education:
Bachelor’s degree in biology, biochemistry, life sciences, engineering, or equivalent required. Advanced degree preferred.
Experience:
Minimum 7 years of progressive quality/regulatory/post‑market compliance experience in in‑vitro diagnostics and/or medical device industry. At least 4 years managing post‑market compliance activities including surveillance, field actions, vigilance, and field actions.
Skills & Capabilities:
Working knowledge of current in‑vitro diagnostics regulations, guidances, and standards specific to post‑market requirements.
Advanced verbal and written communication, scientific writing, and presentation skills.
Advanced ability to lead, collaborate, and influence cross‑functional teams without direct authority.
Advanced project management skills – manage multiple assignments, identify and mitigate risks, develop proactive approaches.
Conflict resolution, critical thinking, decision making, data‑driven analysis.
Proficiency with Microsoft Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, Adobe Acrobat).
Technical Expertise:
Strong understanding of IVD product principles – reagents, calibrators, controls, software, instruments.
Familiarity with immunoassays, ELISA, chemiluminescent assays, multiplex platforms.
Ability to interpret, analyze and present data for regulatory adverse events, vigilance, field actions, and surveillance reports.
Regulatory & Vigilance Competency:
Expertise in interpreting, analyzing, summarizing, and presenting complex data in post‑market documentation.
Experience drafting scientifically sound regulatory reports and interacting with agencies on post‑market events.
Travel Requirements:
None routine required.
The salary range for this position is currently $85,000–$127,000 annual. Individual compensation is based on the candidate’s qualifications, experience, skills, education, certifications, internal equity, budge, and business needs.
Work Environment Physical demands: frequently communicate, detect and inspect scientific data, stand or walk up to 8 hours/day, sit up to 8 hours/day, use hands for keyboard, telephone, pipettes or lab equipment, reach with hands and arms, climb stairs, balance, stoop, kneel or crouch, talk and hear, meet vision requirements, occasionally lift up to 25 pounds. Noise level moderate, high activity, mobility required.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Equal Opportunity Employer Werfen is an Equal Opportunity employer and is committed to a diverse workplace. We strictly prohibit unlawful discrimination, harassment or retaliation based upon 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 state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact talentacquisition@werfen.com for assistance.
Company Overview We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees worldwide comprise our Werfen team.
www.werfen.com
#J-18808-Ljbffr
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 The Senior Post Market Compliance Specialist will ensure compliance for on‑market devices with post‑market global regulations for post‑market surveillance, reportable events, vigilance, and field actions. The position will lead cross‑functional teams in post‑market assessments and execution of surveillance, reportability, vigilance, and field actions. The Specialist will represent the company in interactions and communications with regulatory authorities and notified bodies on post‑market reporting.
Responsibilities
Field Actions:
Perform assessments to determine whether an issue requires a field action in impacted geographies. Coordinate internal actions, work directly with relevant agencies, manage field action activities, author Health Hazard Evaluation reports, draft and send notifications, and author field action reports to relevant agencies. Compile and review assessments and execution records to ensure compliance with AID procedures and relevant regulations. Represent the company in post‑market regulatory communications.
Post‑Market Surveillance Program:
Act as subject‑matter expert on global post‑market surveillance requirements. Analyze inputs, create PMS review schedules, adjust as needed, research and analyze regulatory data, lead cross‑functional teams in gathering, analyzing post‑market data, evaluating trends, forming action items, and compiling reports. Ensure transfer of action items into CAPA and Design Control systems and maintain PMS documentation records.
Reportable Events:
Lead and coordinate timely investigations into all potentially reportable incidents, adverse events, and device malfunctions related to Autoimmunity medical devices. Document investigations, decisions and submit mandatory reports to global regulatory agencies. Maintain event records.
Quality Management System Support:
Educate and broaden regulatory knowledge within Werfen teams, benchmark processes, author and maintain departmental procedures and templates, support post‑market function, assist other QRC departments in audit and inspection preparation, and summarize post‑market data for Management Review Meetings.
Comply with all applicable SOPs, QMS regulations, EHS, Human Resources and other policies.
Reflect Werfen values in quality of work and working relationships.
Networking/Key Relationships:
Manufacturing teams
QA, QE, QPS, and Regulatory teams
R&D teams including Manufacturing Technical Support
Marketing and Commercial Teams
Contract manufacturers and suppliers
Senior and Executive Management
Affiliates
Other Werfen departments and staff
Regulatory Agencies (Domestic and International)
Qualifications Minimum Knowledge & Experience Required
Education:
Bachelor’s degree in biology, biochemistry, life sciences, engineering, or equivalent required. Advanced degree preferred.
Experience:
Minimum 7 years of progressive quality/regulatory/post‑market compliance experience in in‑vitro diagnostics and/or medical device industry. At least 4 years managing post‑market compliance activities including surveillance, field actions, vigilance, and field actions.
Skills & Capabilities:
Working knowledge of current in‑vitro diagnostics regulations, guidances, and standards specific to post‑market requirements.
Advanced verbal and written communication, scientific writing, and presentation skills.
Advanced ability to lead, collaborate, and influence cross‑functional teams without direct authority.
Advanced project management skills – manage multiple assignments, identify and mitigate risks, develop proactive approaches.
Conflict resolution, critical thinking, decision making, data‑driven analysis.
Proficiency with Microsoft Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, Adobe Acrobat).
Technical Expertise:
Strong understanding of IVD product principles – reagents, calibrators, controls, software, instruments.
Familiarity with immunoassays, ELISA, chemiluminescent assays, multiplex platforms.
Ability to interpret, analyze and present data for regulatory adverse events, vigilance, field actions, and surveillance reports.
Regulatory & Vigilance Competency:
Expertise in interpreting, analyzing, summarizing, and presenting complex data in post‑market documentation.
Experience drafting scientifically sound regulatory reports and interacting with agencies on post‑market events.
Travel Requirements:
None routine required.
The salary range for this position is currently $85,000–$127,000 annual. Individual compensation is based on the candidate’s qualifications, experience, skills, education, certifications, internal equity, budge, and business needs.
Work Environment Physical demands: frequently communicate, detect and inspect scientific data, stand or walk up to 8 hours/day, sit up to 8 hours/day, use hands for keyboard, telephone, pipettes or lab equipment, reach with hands and arms, climb stairs, balance, stoop, kneel or crouch, talk and hear, meet vision requirements, occasionally lift up to 25 pounds. Noise level moderate, high activity, mobility required.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Equal Opportunity Employer Werfen is an Equal Opportunity employer and is committed to a diverse workplace. We strictly prohibit unlawful discrimination, harassment or retaliation based upon 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 state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact talentacquisition@werfen.com for assistance.
Company Overview We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees worldwide comprise our Werfen team.
www.werfen.com
#J-18808-Ljbffr