Director, Regulatory Affairs

Argon Medical Devices Inc•Plano, TX

7d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.