Manager, Vigilance and Regulatory

Job Description

Job Description

SUMMARY

Working within the Quality and Regulatory function this position manages the complaint investigation function, as well as performing regulatory affairs functions. This position manages staff performing complaint investigations / laboratory experiments and generates formal reports related to those activities such as product performance surveillance, improvement of production efficiencies and product / process validation and improvement. These tasks include the investigation and closure of complaints, assistance with process validations, including acceptance criteria and assistance with the transfer of product improvements and new products to manufacturing from development, together with cross-functional departments to monitor key performance indicators (KPI) in the effort to achieve better process efficiencies. This position has the primary responsibility of maintaining compliance through global reporting of adverse events such as MDRs and Vigilance reporting. This position remains attentive throughout the complaint investigation process to ensure complaints are fully investigated and their findings are conveyed to the appropriate components of the quality system. The position also performs regulatory affairs product registrations / tasks as assigned, including new registrations, maintenance of existing registrations, and support of distributors / colleagues.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manages the complaint resolution process, including ensuring adequacy of processes used for complaint investigation and reporting.
• Manages global Vigilance, MDR, and adverse event reporting.
• Key contributor in Field Corrective Actions and recalls.
• Manages department that conducts investigations and / or experiments to test system performance which may include chemistry, architecture, and / or analyzer issues relating to all complaints.
• Subject matter expert for complaint investigations, and associated processes / procedures. Represents department during audits.
• Conveys complaint investigation findings to upper management and elevates findings if warranted.

Ensure complaints are fully investigated, conduct further action as required and close within target time frames.

QUALIFICATIONS

Clinical chemistry analyzer(s)

EDUCATION and / or EXPERIENCE

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position typically works in a laboratory and office environment. Lab coat, safety glasses, and gloves are required and provided when performing laboratory analysis.

EQUAL OPPORTUNITY EMPLOYER

PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This Job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.

Company Description

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success : People, Technology and Service.

Company Description

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success : People, Technology and Service.