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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
The Regulatory Affairs Manager will develop and execute regulatory plans for complex projects. He/She will also have responsibility for the maintenance of licenses/authorizations for existing marketing authorizations. This person will provide regulatory support to cross functional project teams as well as prepare core dossier/STED and provide support for major market regulatory approvals. He/She will manage product and/or product family submissions concurrently in several countries with significantly differing regulatory schemes as well as provide post-market support and ensure regulatory compliance of market-released products.
Essential Duties and Responsibilities
Lead and maintain global product registration strategy and planning
Provide regulatory support, and leadership to project teams for regulatory issues and questions and ensure that regulatory requirements are addressed prior to submission for market clearance
Work closely with Marketing, Manufacturing, Quality Assurance, R&D, Medical Affairs and New Product Development teams to provide strategic regulatory guidance and review Prepare core dossier/STED for U.S. and international submissions for products with significant changes
Support Baxter affiliates and distributors to prepare and maintain product submissions and licenses
Understand global regulatory requirements and establish and maintain good working relationships with regulatory agency personnel/Baxter in-country colleagues
Support market-released products by reviewing Engineering Change Orders, labeling, etc. to ensure compliance with regulatory requirements
Evaluate proposed product changes for regulatory impact and preparing necessary documentation
Provide value-added improvements to departmental standard procedures (SP) by authoring original or editing existing standard procedures
May supervise and train junior level regulatory affairs department employees
Qualifications for this role
Strong analytical and strategic thinking skills
Excellent oral, written and interpersonal skills
Demonstrate ability to manage multiple projects and priorities simultaneously
Experience with medical devices with specific experience in: Class I, II, and III medical devices (and/or pharmaceuticals), 510(k) applications and US device regulations and Global medical device regulations and submissions (EU, Canada, Australia, Asian countries, Latin American countries, and Middle Eastern countries)
Proficient computer skills
Education and Experience
Bachelors degree or country equivalent in related scientific discipline Greater than 7 years of regulatory experience
Minimum of two to three years medical device industry experience
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generat...ion of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.