Sr. EU Post Market Surveillance Analyst
Sr. EU Post Market Surveillance Analyst
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position:
The Post Market Surveillance Sr. Analyst supports the Regulatory Department by reviewing evaluating and performing follow up activities on all product complaints determining if they require vigilance reporting identifying supporting data notifying regulatory agencies and responding to their requests related to vigilance reporting as necessary.
Roles and Responsibilities:
Main activities
- Evaluates and reports device malfunctions and adverse events involving company products to the European competent authorities.
- Responds to European competent authoritys requests related to vigilance reporting.
- Collect trend and escalate data related to Post Market Surveillance.
- Independently advises cross-functional teams on vigilance reporting requirements.
- Support training of new team members.
- Acts as an interface between EMEIA customer support team Regulatory Post Market Surveillance team in US and European customers including distributors.
Additional 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 complaints 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.
- Support Quality Management system activities such as CAPA Field Safety Corrective Actions documentation training management review and internal & external audits as needed.
- Assists and supports other employees teams and field personnel as necessary.
- Other regulatory tasks and projects may be assigned as necessary.
Qualifications :
Required Knowledge Skills and Experience:
- In-depth knowledge and understanding of the European Medical Device Directive 93/43/EEC MEDDEV 2.12-1 and EU Medical Device Regulation EU/2017/745
- In-depth knowledge of quality records requirements and how they apply to complaint files and post market surveillance reports.
- A bachelors degree or Swiss CFC (Health sciences preferred)
- 2-3 years of experience in Post Market Surveillance 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.
- Good problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
- 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 at least another European language (French or German preferred)
- General Computer literacy (PC Microsoft Word/Excel/PowerPoint Outlook)
Preferred Knowledge Skills and Experience:
- 3 5 years of experience in a Medical Device environment
- US FDA 21 CFR 803/806/820 knowledge would be a plus.
- Ideally possessing other third language skills for the European market
- Experience with software such as TrackWise ERP / CRM (e.g. SAP) or Salesforce is a plus.
Additional Information :
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
