Primary Function of Position:
The Post Market Surveillance Specialist supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and identifying supporting data.
Roles and Responsibilities:
Main activities
- Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints.
- Processes, records, and closes complaint-handling activities in a timely manner.
- Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes.
- Determines reportability of complaints per regulatory reporting requirements.
- Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors.
Additional activities
- Evaluates and reports device malfunctions involving company products to the European regulatory agencies.
- Collect, trend, and escalate data related to Post Market Surveillance.
- Assists and supports other employees, teams, and field personnel as necessary.
- Otger regulatory tasks and projects may be assigned as necessary.
Required Knowledge, Skills, and Experience:
- Knowledge / understanding of the European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1.
- Understanding of quality records requirements and how they apply to complaint files and post market surveillance reports.
- A Bachelor’s degree or Swiss CFC (Health sciences preferred).
- 6 months – 2 years of experience in complaint handling for medical devices.
- Ability to handle multiple tasks, to prioritize and schedule work to meet business needs.
- Demonstrate organizational and planning skills, including action oriented; focus urgency and driving for results.
- Demonstrate good communication skills, over the phone, in person and in writing.
- Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
- Ability to guide customers in providing key relevant data for case management.
- Orientation for work result details, with emphasis on accuracy and completeness.
- Fluent (C1 minimum) in written and spoken English and German.
- General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).
- US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) basic knowledge would be a plus.
- Ideally possessing other third language skills for the European market.
- Experience with software such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
