Quality & Regulatory Director

Nuwellis, Inc. • Eden Prairie, MN

4h • Onsite

About The Position

Nuwellis, Inc. is a medical device company focused on improving the lives of patients suffering from fluid overload through our Aquadex SmartFlow ultrafiltration therapy. Our team is passionate about developing technology that helps clinicians treat critically ill patients more effectively. We are seeking a Quality & Regulatory Director to lead Nuwellis Quality & Regulatory, direct day-to-day operation of the Quality Management System, and serve as Nuwellis’ in-house regulatory expert for US, EU, and global compliance. This role is responsible for implementation and maintenance of Quality System procedures related to oversight of contract manufacturing, operations, document and record control, customer feedback/complaint handling, and internal and external audits to assure compliance to Quality System Regulations (QSR), ISO, and other applicable requirements. This role leads the development of regulatory strategy, preparation of submissions, supports new product development, maintains regulatory compliance of products/organization and interfaces with worldwide regulatory bodies. This role is ideal for someone to be an individual contributor as well as a strategic leader. This position requires prior experience working in a regulated medical device environment and hands-on experience with FDA Quality System Regulations and ISO 13485. This is an onsite position, requiring a full-time in-person presence at Nuwellis' corporate office in Eden Prairie, MN.

Requirements

• Bachelor’s degree in a technical field or scientific discipline.
• 10+ years of experience in the medical device industry with class II or class III products, with 5+ years of experience leading people, projects, programs and/or departments.
• Experience with overseeing contract manufacturing and product acceptance requirements.
• Significant experience with ISO 13485.
• Ability to think independently and make sound strategic quality and regulatory decisions.
• Ability and willingness to work on-site in Eden Prairie, MN.
• Must be eligible to work in the U.S. without employer sponsorship.

Nice To Haves

• Previous direct managerial experience strongly preferred.
• Demonstrable direct and effective working relationship with worldwide regulatory bodies.
• Demonstratable experience developing and interpreting standards, guidelines and special controls.
• Extensive knowledge of standards and regulations with ability to integrate into projects.
• ASQ CQE or other similar quality or regulatory certification.
• Demonstrated ability to develop strong and appropriate consultant relationships.
• Grand Avenue Software experience a plus.

Responsibilities

• Hands on Quality Leader responsible for the overall Quality Systems and Regulatory compliance (e.g. ISO 138485, QMSR).
• Manage Document and Record Control, training, CAPA, Change Control and Feedback and Complaint Systems.
• Ensure Corrective Actions are comprehensive, effective and timely.
• Maintain working knowledge of existing and emerging regulations, standards and guidance documents applicable to the business (including interpretation, communication of potential impact to senior leadership, and assisting in implementing actions to assure compliance).
• Develop quality plans to ensure corporate and compliance objectives are met.
• Oversight and management of supplier quality to support supplier selection and approval, audits and CAPA.
• Identify and analyze quality trends and propose and implement strategies and projects to maximize and optimize overall quality performance.
• Act as regulatory representative in internal and external meetings.
• Assist in ensuring the company is in a constant state of readiness for regulatory inspections. Lead role in management of regulatory agency inspections and certification/accreditation body audits.
• Develop regulatory strategy and identify deliverables for new product submissions and design changes as appropriate.
• Prepare FDA and other worldwide regulatory submissions (e.g. applications, IDE Supplements, Design Dossier Amendments, Annual Reports, etc.) and other regulatory related documentation.
• Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel.
• Provide support for currently marketed products, including review of engineering changes, process changes, and labeling changes.
• Maintain regulatory systems that overlap with Quality Systems, such as complaint handling and reporting, implant/tracking registries, and labeling.
• Interviewing, hiring, training and developing employees; establishing and communicating expectations; planning, monitoring, and appraising job results; rewarding, coaching, and disciplining employees; addressing concerns and resolving problems; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.

Benefits

• Annual discretionary bonus
• Health insurance (multiple plan options), including an HDHP with an annual company contribution of $2,000 (individual) / $4,000 (family)
• Company contribution toward dental and vision coverage
• Employer-paid life insurance (up to 1x annual salary), short- and long-term disability, and PFML
• Paid time off including PTO, floating holidays, and 8 company holidays
• 401(k) plan with a 3% company match

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1-10 employees