Principal Regulatory Affairs Specialist

Regulatory Affairs ManagerResponsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.Key AccountabilitiesEssential Functions:Participates as the regulatory design team member for new and significant changes to IL-labeled product, providing early input on analytical and clinical test requirements, acceptance criteria and regulatory submission strategy.Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan.Performs labeling reviews and Change Order (CO) reviews/signatures for new product and significant product modifications.Prepares FDA 510(k), Health Canada license and EU Notified Body submissions for new products and significant modifications, coordinating deliverables with R&D and Marketing, authoring summary analytical and clinical reports, interfacing with Regulatory agency/Notified Body and advising on strategies and requirements throughout the registration process.Reviews and approves commercial materials for compliance/consistency with registrations, including by not limited to brochures, presentations and training materials.Other regulatory activities as needed to support new product launches and significant product modifications.Budget Managed (if applicable): N/AInternal Networking/Key Relationships: To be determined based on department needs.Skills & Capabilities:Effective verbal communication in individual and group settingsStrong writing skills for submission preparationDetail oriented with good organizational skills and able to meet deadlinesAbility to prioritize while balancing multiple projects, with strong planning skillsEffective decision makerMinimum Knowledge & Experience Required for the Position:Requires a Bachelor degree, preferably in regulatory or science related areasMinimum of 8-years' regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experienceExperience in the preparation of regulatory submissions to US FDA, Health Canada and/or EU Notified Body with in the past 8 years.Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulatory, MDSAP Companion Document, with some exposure to either EU MDR or EU IVDREffective verbal and written communication in individual and group settingsAbility to prioritize and balance work load, with minimal supervision and in a fast pace environmentLanguage fluency: English essentialInternational Mobility: Required: NoTravel requirements: 5-10% of time per year, domestic and internationalThe annual base salary range for this role is currently $150,000 to $180,000. 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 View email address on click.appcast.io for assistance.