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Oxenham Group · 1 week ago

Senior Regulatory Affairs Specialist

Minneapolis–Saint Paul, WI

Full-time

Onsite

Mid, Senior Level

3+ years exp

Oxenham Group is seeking a detail-oriented Regulatory Affairs Specialist to support compliance, quality management, and regulatory activities within the sterile processing / medical device division. This role ensures adherence to international regulations and standards, supports product registrations, and maintains the Quality Management System (QMS).

ConsultingHuman ResourcesRecruiting

Responsibilities

Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR, Health Canada, and international registrations)

Serve as primary contact with regulatory authorities, notified bodies, and certification agencies

Monitor evolving regulatory requirements and communicating impacts to leadership

Provide regulatory guidance on new product development, product changes, labeling, and marketing materials

Advise internal teams on compliance impacts to product development and market access

Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards

Support internal and external audits, inspections, and corrective actions

Ensure proper document control, training, and change management processes

Partner with R&D, manufacturing, and clinical teams to ensure compliance with design control, risk management, and post-market surveillance

Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes

Support complaint handling, vigilance reporting, and CAPA activities

Provide regulatory and quality guidance during new product development

Liaise with regulatory authorities, notified bodies, and certification agencies

Train employees on regulatory and compliance topics

Perform additional duties as assigned

Qualification

Regulatory AffairsISO 13485Regulatory SubmissionsFDA RegulationsEU MDRQuality Management SystemAnalytical SkillsRegulatory CertificationsOrganizational SkillsCommunication Skills