Director, Market Quality

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

Position Summary:

The Director, Market Quality will be responsible for overseeing the team responsible for the Transformation and Governance of the Post Launch Complaint Handling System at Recor Medical and serve as a global Market Quality subject matter expert.

Responsibilities include managing a growing team of Product Complaint Investigators who support commercial post-market activities, decision making regarding complaints from clinical and sponsored studies, investigation, health hazard evaluation, escalation, transformation. The position requires experience leading and developing teams through commercialization.

The position will work cross-functionally with the global organization. The position reports to the Sr. Vice President, Quality and Regulatory Affairs.

Responsibilities & duties:

• Oversee market quality processes and teams to support Recor goals

• Responsible for complaint investigations, MDR and Vigilance Reporting decision making, and provide subject matter expertise to clinical, scientific, commercial, QA/RA, R&D and other areas of necessary support.

• Oversight and development of market quality team.

• Lead Transformation to Mature Worldwide Complaint Handling System including inputs from Clinical Studies, Field Service, Sales Reps, including web-based data gathering.

• Oversight and guidance to team conducting detailed product analysis and liaison with Product Subject Mater Experts.

• Liaison with Medical Affairs regarding initiation of complaints from on-going clinical studies. Ensure timely and appropriate global medical review for clinical and post-market programs

• Lead strategic decision making, health hazard evaluation, and escalation to support appropriate complaint response for potential recalls/ stop shipment actions in critical situations.

• Lead development of appropriate trending and metrics for distribution and for management review

Requirements:

• Salary to commensurate with experience

• Minimum of 10 years’ device/pharmaceutical/clinical experience

• Experience Leading or Developing a Mature Complaint Handling System

• Experience with Trending and Tracking

• Experience with MDR and Vigilance decision making and Escalation

• Experience with Health Hazard Evaluation

• Experience in medical devices and cardiovascular areas (preferred)

• Technical Aptitude to understand failure modes of the product

• Required collaboration and critical thinking

• Knowledge of good clinical practice and regulations

• Local to Bay Area, CA

• Strong communication and presentation skills

Salary Range: $232,997 - $259,290 (Annual Base Salary)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. 

Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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