Director, Regulatory Affairs

Director, Regulatory Affairs Argon Medical Devices Inc - 3.2 Plano, TX Job Details Full-time 9 hours ago Qualifications Optimizing workflow processes FDA submissions Compliance risk assessment Performance improvement leadership Strategic management ISO standards Bachelor of Science Professional ethics Bachelor's degree in biomedical engineering Legislative impact assessment Biomedical Engineering GMP Regulatory legal research 8 years Team development Collaboration with product development teams Analysis skills Bachelor's degree Medical device manufacturing facility experience Decision making Master of Science Quality improvement Quality compliance management Mentoring Document review Leading team collaboration initiatives Regulatory/legal compliance standards in production Regulatory submission editing and review Biomedical regulatory compliance Senior level

Full Job Description Company Overview:

: Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon's brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

Position Overview:

: The Director, Regulatory Affairs is responsible for leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams and managing critical interactions with regulatory agencies across the globe.

What you will do:

: Oversee and provide expert guidance on regulatory requirements and ensure successful product submission strategies across multiple jurisdictions. Working closely with cross-functional teams, this role will shape regulatory strategy for product development, product changes, manufacturing and commercialization while ensuring global compliance is maintained. Actively communicate and collaborate with internal and external partners and across functions including Marketing, Commercial Regional Leaders, Engineering, R D, Site Quality, Operations to support new product development and global registration strategy. Identify, implement and maintain process improvements for global registrations, with particular focus on USFDA, EUMDR, UK and China. Review and interpret regulatory and compliance requirements and guidance document as they related to company products, processes and QMS. Monitors external device enforcement trends and provides detailed recommendations and action plans to address QMS approvements. Mentor and develop regulatory affairs and cross functional teams. Completes impact assessment of new regulations and document applicability for both Argon-branded and CPS manufactured lines. Maintains current knowledge of external legislation, standards, guidelines, industry practices, and FDA submission requirements that impact medical devices and combination products. Maintains active memberships and participation within relevant external medical device and combination product industry groups and committees. Skills for

Success:

: BS/MS in either (Biomedical) Engineering, Science, or a related field. 8-12 years' progressive experience at a global manufacturer of medical devices or at a regulatory agency. Comprehensive knowledge of global regulatory requirements including FDA and global health authorities (EUMDR, Japan PMDA, ANVISA, MFDS, Health Canada, etc.). Demonstrated expertise in regulatory compliance and quality management systems includes review, assessment and conformance to global regulatory standards. Expert knowledge of FDA regulations, MDSAP, ISO 13485, ISO 14971, IEC 62366, IEC 62304 etc. Strong knowledge of Quality, Regulatory Compliance, and operations systems and processes, including GMP, GCP and QMSR requirements for medical devices Strategic thinking and analytical skills with the ability to interpret and apply regulatory requirements and industry best practices. Strong analytical, organizational, communication, and interpersonal skills are required. Excellent leadership, management, collaboration, and effective decision-making skills Excellent interpersonal skills, negotiation and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel. Ability to work in fast paced environment and rapidly shifting priorities while maintaining high ethical standards and integrity. 10 - 20% travel required.