Senior Manager, Regulatory Affairs/Quality AssuranceVENTUREMED GROUP LTD • United States
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Senior Manager, Regulatory Affairs/Quality Assurance
VENTUREMED GROUP LTD
- United States
- United States
À propos
is a fast-growing MedTech innovator advancing vascular and endovascular care, headquartered in Plymouth, MN. Founded by vascular surgeon Dr. John Pigott, the company developed the
FLEX Vessel Prep System , a minimally invasive, non-balloon endovascular tool designed to optimize vessel preparation and improve outcomes in AV fistula, graft, and peripheral interventions. Backed by a seasoned leadership team with multiple MedTech scale-and-exit successes, VentureMed is entering a major commercial growth phaseexpanding nationally and building its clinical and reimbursement infrastructure. Why Youll Love It Join an experienced leadership team with deep vascular and endovascular expertise and a proven track record of building and exiting successful MedTech companies. Help advance a first-in-class technology with strong clinical evidence, FDA clearance, and active reimbursement momentum through a current TPT designation. Play a foundational role in shaping and scaling VentureMeds commercial organizationbuilding process, culture, and impact in a company on the rise. Position Overview:
The Manager of Regulatory Affairs/Quality Assurance position will be responsible for developing and implementing strategies for worldwide governmental approval to introduce new products to market, provide advice on regulatory requirements, and prepare regulatory submissions and negotiate their approval. Drive regulatory support across all functional areas to deliver superior products, while maintaining ISO 13485 and MDR certification as well as compliance with FDA regulations and any other market-driven regulatory requirements. Drive regulatory/quality strategies, and continuous improvement efforts. Influence product development, regulatory approvals, and quality assurance practices, ensuring our products exceed industry standards and improving patient outcomes worldwide. Key Responsibilities: Strategic Leadership:
Develop forward-thinking regulatory/quality strategies that align with corporate objectives and global regulatory landscapes. Lead cross-functional teams to foster a culture of quality, compliance, and continuous improvement across the business. Essential Duties and Responsibilities:
Serve as the regulatory expert for global market entry, product labeling, and manufacturing and sales support activities. Develop and implement Regulatory strategies/plans, domestic and international, to ensure smooth product introduction and continuous support for currently marketed products for VentureMed and its distributors and partners. Prepare FDA submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory issues with Senior Management, as necessary, and negotiate submission issues with agency personnel. Maintain the Regulatory files for the company. Provide on-going support to product development teams regarding regulatory issues, including submissions, and process control per the Quality System. Manage International registration ensuring up-to-date registrations. Review International growth strategy and proactively seek registration in select countries. Provide support for currently marketed products, including reviewing labeling, promotional material, product changes, web site content, and technical publications. Maintain relationships with government agencies and respond proactively to the development and changes of laws, regulations, and certifications. Develop general strategies on how to interact more effectively with agencies and their respective personnel. Navigate complex regulatory environments, providing expert guidance during audits, inspections, and regulatory interactions. Monitor changes in regulatory requirements and assess the impact on company products and processes, ensuring proactive compliance. Collaborate with cross-functional teams to support development and sales and marketing of VentureMed products. This includes supporting regulatory strategy development, submission preparation, and overall compliance oversight. Provide regulatory input during product development phases to ensure that products meet applicable regulatory standards and requirements. Decision-Making Authority:
Approve critical regulatory/quality documents and compliance-related decisions. Influence strategic planning and risk management initiatives. Qualifications:
Education:
Bachelors degree in Life Sciences, Engineering, or related field. Experience:
5+ years in Regulatory roles within the medical device industry, with a strong track record of leadership. Expertise:
In-depth knowledge of ISO 13485, FDA regulations, EU MDR, risk management (ISO 14971), and international regulatory requirements. Skills:
Filing submissions, exceptional leadership, strategic thinking, problem-solving, and communication abilities.
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Compétences linguistiques
- English
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