Regulatory Affairs Specialist III

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.Position Summary:This position is responsible for ensuring that pre?market and/or post?market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross?functional software development meetings; prepare software?specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.Key AccountabilitiesEssential Functions:Advise and direct teams on regulatory requirements related to new product development or significant changesEnsure test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s)Author regulatory plans as regulatory lead for new products or significant product changes, including interfacing with country market approval holders to confirm local regulatory requirementsAct as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and internationalReview and approve labeling and marketing materials associated to regulatory filingsAdvise and direct teams on regulatory requirements for on-market product changesAuthor regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirementsEnsure company site and device registrations are compliant with applicable domestic and international regulationsReview and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as requiredIncrease working knowledge of regulations, standards, company SOPs and toolsAssist in interactions regarding regulatory affairs with all functional areas of the company as required including senior managementAssist in tracking standards, regulations and all applicable requirementsOther duties as assignedSecondary Functions:Assesses regulatory gaps and take the appropriate corrective actions, as neededSupports internal and external audit as requiredParticipates in regulatory improvement projects as requiredBudget Managed (if applicable)N/AInternal Networking/Key RelationshipsTo be determined based on department needs, to include interactions such as:Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirementsAbility to negotiate and influence others in establishing direction toward improved regulatory and enhanced complianceAbility to effectively communicate regulatory requirements to a broad population of constituentsSkills & Capabilities:The ideal candidate for this position will exhibit the following skills and capabilities:Ability to read and interpret domestic and international regulatory/quality standards related to our productsWorking knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirementsDemonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectivesRecognition of when to escalate issues to management or consult with more senior staff members.Competencies:Attention to Detail: Ability to pay close attention to detail is requiredAccuracy: Work is accurate and completePerformance Standards: Demonstrated ability to meet department goalsCommunication: Excellent written, verbal and presentation skillsDiscretion: Acts with integrity in all situations and can maintain appropriate confidentialityMulti-Tasking: Ability to manage multiple priorities, and support changing business needsCollaboration: Ability to work within a team to bring best solutions to the team or customerIndependence: self-motivated-works under minimal supervisionProfessionalism: Must demonstrate professionalism during all interactions within company, customer and third partiesTakes Initiative: Serves as a role model for 'Quality First' by continuously improving on what matters most to customersProblem Solving: Promptly and effectively handles issues and problemsDecision Making: Makes decisions based on data and risk determinationMinimum Knowledge & Experience Required for the Position:Education: Bachelor's degree or higher, preferably in science and/or regulatoryExperience: Minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degreeAdditional Skills/Knowledge:Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulationsUnderstanding of the application of regulatory principles in the areas of pre-market or post-market complianceKnowledge of FDA, ISO, MDSAP and international country regulations Knowledge of design control requirements and understanding of GMP Language: EnglishInternational Mobility:Required: NoTravel Requirements:<10% of timeThe annual base salary range for this role is currently $105K to $130K.Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.Our sales roles are eligible for participation in a commission plan and our management,and select professional roles,are eligible for a performance-based bonus.If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s 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 assistance.We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

Created: 2026-03-05