Transcend Inc. is a medical device company dedicated to innovation and the people we serve. We are the manufacturer of market-leading travel CPAP machines, helping those people with sleep apnea wherever they go. Our current device is about the size of a baseball – the smallest in the industry. We are highly focused not just on continuous improvement, but also continuous innovation to meet the requests of our customers.  We are currently seeking a Manager or Director of Quality and Regulatory (title to be based on experience). Join us in making a meaningful impact on the health of our customers.

The Manager/Director of Quality & Regulatory is responsible for leading Quality and Regulatory at Transcend, managing day-to-day operation of the Quality Management System, and serving as our in-house regulatory expert for US and global compliance.

This position is responsible for implementation and maintenance of Quality System procedures related to operations, document and record control, customer feedback/complaint handling, and internal and external audits to assure compliance to Quality System Regulations (QSR), ISO, MDSAP, and other applicable requirements.

The Manager/Director of Quality & Regulatory 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 is an onsite position, requiring a full-time in-person presence at our corporate office in Fridley, MN.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Quality Management Representative; Responsible for the overall Quality Systems and Regulatory compliance (e.g. ISO 13485, 21 CFR 820, MDSAP).
• Oversee Quality Assurance and Quality Control activities within the organization.
• Act as regulatory representative in internal and external meetings.
• 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.
• Develop quality plans to ensure corporate and compliance objectives are met.
• 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.
• Oversee and manage 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.
• Develop regulatory strategies and identify deliverables for new product submissions and design changes as appropriate.
• Prepare FDA, and other worldwide regulatory submissions.
• 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, and labeling.
• General Management Responsibilities: 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.

MINIMUM QUALIFICATIONS

• Bachelor’s degree and 10+ years of relevant experience.

PREFERRED QUALIFICATIONS & COMPETENCIES

The ideal candidate will thrive in a small, hands-on environment where they are personally accountable for the success of our quality and regulatory systems. To succeed in this role, the individual must demonstrate: integrity and strong ethical judgment; a calm, focused demeanor under pressure; adaptability to ambiguity and changing priorities; excellent communication and collaboration skills across functions; and the ability to build credibility with auditors, regulators, and internal stakeholders alike. They should possess a builder mentality, be a self-starter with ownership of outcomes, and balance a pragmatic approach to risk with rigorous compliance. The ability to influence without authority and to hold others accountable—including senior leaders—is essential.

• 10 years of experience in the medical device industry with some class II product experience.
• A work history which includes experience at a small company.
• Direct experience running a full quality management system.
• Demonstrable direct and effective working relationships with regulatory bodies and auditors.
• Demonstrable experience developing and interpreting standards, guidelines and special controls.
• Extensive knowledge of standards and regulations with ability to integrate into projects.
• Significant experience with ISO 13485.
• Demonstrated ability to develop strong and appropriate consultant relationships.
• Ability to think independently and make sound strategic regulatory and quality decisions.
• Experience in application of statistical methods to design reliability and process capability.

Additional Information

Transcend Inc. is a manufacturer of award-winning continuous positive airway pressure (CPAP) medical devices. Since launching the world’s first travel-sized CPAP machine in 2012, we have continued to reimagine the functionality of small, portable CPAP machines. We are driven by our mission to provide sleep therapy solutions that allow CPAP users to successfully maintain their therapy regardless of lifestyle, travel plans or sleep location. 

Compensation: Compensation will be based on the experience and work history of the candidate.

Benefits: We offer benefit plans that include medical, dental and life insurance, short and long-term disability coverage, 401(k) and paid holidays / personal time off.

How to Apply

Qualified candidates should submit to [email protected] their resume and a cover letter highlighting their relevant experience and why she/he is a good fit for this role. Transcend Inc. is an equal opportunity employer.