VentureMedGroup, Ltd. ยท 21 hours ago
Senior Mgr - Reg Affairs / Quality Assurance
Twin Cities Area
Full-time
Onsite
Senior Level
$140K/yr - $160K/yr
5+ years expVentureMedGroup, Ltd. is a fast-growing MedTech innovator advancing vascular and endovascular care. The Manager of Regulatory Affairs/Quality Assurance will be responsible for developing and implementing strategies for worldwide governmental approval to introduce new products to market and ensuring compliance with regulatory requirements.
Medical Device
Responsibilities
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
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
Approve critical regulatory/quality documents and compliance-related decisions
Influence strategic planning and risk management initiatives
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or related field
5+ years in Regulatory roles within the medical device industry, with a strong track record of leadership
In-depth knowledge of ISO 13485, FDA regulations, EU MDR, risk management (ISO 14971), and international regulatory requirements
Filing submissions, exceptional leadership, strategic thinking, problem-solving, and communication abilities
Company
VentureMedGroup, Ltd.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase