Manager Post Market Surveillance

About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose

This is a key Manager role responsible for leading, and managing the Complaint department, ensuring compliance with global regulatory requirements. This highly visible role will work closely with Customer Service and Technical Support and be responsible for reviewing Customer Feedback/Complaints and identifying reportable events. They will work with cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality to develop investigative tools and techniques for complaint investigations.This role requires significant attention to detail, excellent verbal and written communication skills, and the ability and critical thinking skills to prioritize competing projects.

Duties and Responsibilities

• Develop and implement strategies for handling product complaints, including investigation, reporting, and corrective actions
• Evaluate complaints for reportable events in the US and international agencies
• Utilize an electronic complaint handling and event reporting system. Manage electronic Medical Device Reports for US reportable events
• Oversee the monitoring and trending of complaint data to identify potential product issues and implement preventive measures
• Create a culture of continuous improvement, consistently focused on providing service that adds value to the customer experience
• Demonstrated experience in leading complaint teams in high growth start-ups or established high volume medical device corporations
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development to ensure alignment on technical support and vigilance activities
• Maintain up-to-date knowledge of industry standards and regulatory requirements for medical device complaints/vigilance
• Prepare and present reports to senior management on activities and key performance metrics

Qualifications

• Bachelor’s degree required, advanced degree desired in a Biological, Chemistry, Quality, Engineering or related discipline
• Minimum of 8 years of experience in medical device or biotech industry
• Minimum of 4 years of experience in Technical Support and Complaint Vigilance in a medical device or biotech setting; FDA and ISO regulated industry, MDSAP and or MDR experience a plus
• In-depth knowledge of global regulatory requirements for medical device complaint vigilance, including FDA and EU MDR regulations
• Experience with electronic quality management systems as well as paper-based systems
• Proven leadership experience with a track record of managing teams and complex problems is essential
• Strong analytical skills and the ability to interpret complex data are crucial
• Excellent communication and interpersonal skills are necessary to effectively present information and respond to questions from various stakeholders

Working Conditions

• Work on-site in an open office environment

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.