Regulatory Affairs Specialist II

Position Summary:Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.Key AccountabilitiesEssential Functions:Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requirements, including:Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses).Provide support materials for Milan Regulatory for other country registrations.Assist with product renewal packages to maintain country registrations.Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.Responsible for maintenance of Regulatory Database in SAP.Responsible to review marketing and sign promotional materials for signature by management (as appropriate).Responsible to review and sign labeling and Change Orders (as appropriate).Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.Other assignments related to RA/QA to support Werfen requirements and prioritiesBudget Managed (if applicable):N/AInternal Networking/Key Relationships:To be determined based on department needsSkills & Capabilities:Requires superior communication skills (verbal and written)Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.)Hands on experience working in a regulated environemnt following QMS systems.Previous experience and familiary with In vitro Diagnostics, software in medical device strongly preferred.Experience with SAP is a plus.Minimum Knowledge & Experience Required for the Position:Requires a Bachelor degree, preferably in life sciences or engineering familiarity with ISO 13485 and 14971 preferred.Two years minimum experience in the Medical Device Industry or other highly regulated environment.International Mobility: Required: NoTravel Requirements:Must be available to travel domestically and internationally as needed.<10% per year.The annual base salary range for this role is currently $85,000 range to $105,000 range. 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.

Created: 2025-10-31