Job Title:  Medical Device Vigilance Specialist

Department:  Medical Device

Location: Warsaw, IN- 700 Orthopaedic Drive, Warsaw, IN 46582 (Hybrid 2 To 3 Days a week)

OR 

Wes Cester, PA- 1301 Goshen Parkway, West Chester, PA 19380

JOB SUMMARY

•  This job description covers the purpose, responsibilities, skill sets, and associated training & education required for the Health Authority Reporting Specialist.

• The purpose of the Health Authority Reporting Specialist is to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support. Focus areas are Regulatory Reporting to FDA under 21 CFR, Part 803, Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.

DUTIES & RESPONSIBILITIES

• Demonstrate world class customer support and maintain knowledge of relevant Operating Company’s products and services

• Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include assigning product experience and patient codes. Utilize MD Workflow reports to identify tasks and manage common Email inboxes.

• Make regulatory reporting determinations on applicable files for one or more Business Units. Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint files activities.

• File Medwatch report forms within required timelines as applicable

• File MDVs in accordance to EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable

• Create and/or forward additional information follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management.

• Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process

• Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable

• Manage Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable

• Supporting regulatory additional information requests and actively supporting compliance audits

• Participate in audit and compliance review processes as needed

• Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures

• Participate in assigned projects towards desired business outcomes

• Participate in the onboarding training of new associates and/or existing associates learning a new product

• Participate in escalation process as required

• Partnering and influencing with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters

• Be responsible for communicating business related issues or opportunities to next management level

• Be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Perform other duties assigned as needed

EXPERIENCE AND EDUCATION

• Completed apprenticeship or Baccalaureate degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/Bachelor’s Degree or equivalent experience

• 2-4 Years related experience is desirable (A combination of experience and education can be allowed)

• Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements

• Knowledge of human anatomy, medical terminology and products of applicable Business Units

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Skills Set

• Strong written and verbal communication skills. Fluent spoken/written English required.

• Strong decision-making skills – able to make sound business decisions with sometimes limited information

• Ability to work in a cross-functional and matrix environment

• Ability to work independently

• Continuous Improvement focus

• Time management.

• Ability to handle multiple priorities/ sudden changes in priorities

• Ability to work in stressful/fast paced environment

• Ability to work and interact with co-workers to accomplish company goals in a team environment

• Analytical/Problem Solving Skills

• Ability to learn

• Strong attention to detail

Computer Skills:

• PC computer skills, MS Windows, MS Office (MS Outlook, Word, Excel, PowerPoint) and other communication tools such as Microsoft Teams, Skype, Zoom etc.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Health Authority, MDD, MDR, Regulatory Affairs

#LI-PB1 #LI-Hybrid