Advanced Specialist, Regulatory Product Strategy – Delivery

🕒 vor 2 Monaten

🏄 California – Remote

🏄 California – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🚔 Compliance

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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ResMed

WebsiteLinkedInAlle Stellen

5001 - 10000 Mitarbeiter

Gegründet 1989

⚕️ Krankenversicherung

☁️ SaaS

💰 Post-IPO Debt im 2019-07

Healthcare Insurance • SaaS

ResMed ist ein globaler Marktführer für Schlaftechnologie und respiratorische Versorgung und konzentriert sich darauf, die außerklinische Versorgung zu verbessern, um die Gesundheit und Lebensqualität von Menschen mit chronischen Erkrankungen zu steigern. Seit über 30 Jahren entwickelt ResMed lebensverändernde Technologien und bietet Softwareplattformen an, die medizinische Fachkräfte und Betreuungspersonen dabei unterstützen, Patientinnen und Patienten zu Hause oder in bevorzugten Versorgungsumgebungen beim Gesundheitsmanagement zu begleiten. Das Unternehmen bekennt sich zu Diversität und Inklusion, unterstützt ein breites Spektrum an Fachkräften beim Aufbau einer sinnstiftenden Karriere und gestaltet die Zukunft der vernetzten Gesundheitsversorgung – mit dem Ziel, weltweit das Leben von 250 Millionen Menschen positiv zu beeinflussen.

Beschreibung

• The primary objective of Regulatory Affairs specialization within the Regulatory Affairs Job Family is to provide strategic, tactical and operational direction and support to work within regulations and expedite the development and delivery of safe and effective devices to patients globally. • Act as the Regulatory representative on cross-functional teams, providing strategic regulatory input for new product development, product modifications, and lifecycle management activities. • Maintain awareness of evolving global regulatory requirements and proactively assess regulatory impact on business strategy and product development, translating requirements into actionable regulatory strategies and recommendations. • Provide regulatory guidance to product development by translating regulatory requirements into clear, risk-based recommendations, including intended use, claims, product requirements, and design control activities. • Author and support regulatory submissions/registrations/renewals (e.g., FDA 510(k), EU MDR Technical Documentation, and other global submissions). • Perform regulatory assessments for product and software changes (e.g., software updates, algorithm modifications, labeling updates, and design changes), determining regulatory impact, required actions, and supporting appropriate regulatory pathway decisions. • Evaluate regulatory status of digital health technologies, including regulated and non-regulated software functions, and determine appropriate classification and compliance pathways. • Review and approve labeling, advertising, and promotional materials to ensure alignment with regulatory requirements, approved claims, and intended use. • Support post-market compliance activities, including regulatory inspections, audits, recalls, and collaboration with internal stakeholders and external regulatory bodies (e.g., FDA, Notified Bodies). • Support timely product launches and ongoing market access across regions through effective regulatory execution. • Participate in regulatory interactions with health authorities, including Pre-Submissions, Notified Body consultations, and responses to regulatory inquiries. • Network with senior internal and external personnel within the area of expertise. • May lead the work of project teams and formally train and mentor junior staff.

🎯 Anforderungen

• Bachelor’s degree. • Minimum of 3 years of related experience in a regulated industry as a regulatory affairs professional. • Experience with Software as a Medical Device (SaMD) and/or digital health products. • Experience authoring and contributing to FDA regulatory submissions (e.g., 510(k), De Novo, or equivalent). • Experience working with EU MDR regulatory requirements. • Experience authoring regulatory assessments for product and software changes. • Experience authoring regulatory strategy and submissions across the product lifecycle. • Ability to communicate regulatory concepts effectively to both technical and non-technical stakeholders. • Preferred: 5+ years of related experience in a regulated industry as a regulatory affairs professional. • Experience with AI/ML-enabled medical devices or algorithm-based functionality. • Experience working with cross-functional product development teams in regulated environments. • Experience supporting global regulatory submissions or market access across multiple regions. • Familiarity with regulatory considerations for cybersecurity, data privacy, and data governance in digital health systems. • Experience working in agile or software development environments.

🏖️ Vorteile

• Joining us is more than saying “yes” to making the world a healthier place. • Discovering a career that’s challenging, supportive and inspiring. • Culture driven by excellence helps you not only meet your goals, but also create new ones. • Creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.