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Biosense Webster is recruiting for a Vigilance Specialist , located in Diegem, Belgium
At Biosense Webster, Inc., we have one goal - to help those with cardiac arrhythmias live the lives they want. Are you someone who would like to make an impact to your community? Would you like to work with a highly dynamic and diverse team ,with credo based values? If yes, our job posting may be of interest to you.
The Vigilance Specialist would be responsible to process EMEA complaints and vigilance in accordance with the established company procedures and applicable regulations and standards. The position is responsible to maintain a high level of customer satisfaction and responsiveness to internal and external customers, affiliates as well as EMEA regulatory bodies with regard to product complaints or inquiries.
We are looking for a highly enthusiastic colleague with an eye for detail, who is eager to learn and open to new challenges.
We look forward to hearing from you!
Qualifications
Key Responsibilities:
- Possesses understanding of complaint management for the review of complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and Customer Quality expectations. Utilize MD Workflow reports to identify tasks and manage common Email inboxes
- Make regulatory reporting determinations on applicable files for the applicable Business Unit. Execute file reviews, making and/or reassessing Medical device vigilance(MDV) decisions and managing relevant complaint file activities.
- File MDVs in accordance to EEA, Northern Ireland and Turkey, candidate countries and other third countries guidelines (CH, UK, …) within the required timelines as applicable
- Manage Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with EU regulations as applicable
- Support regulatory additional information requests and actively support compliance audits
- Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process
- Participate in assigned projects towards desired business outcomes
- Participate in the onboarding training of new associates and/or existing associates
- Partner and influence with stakeholders both internally and externally to drive needed change and/or execution of complaint related matters
Qualifications
Education:
- BS degree in science (preferred) with 2-3 years of experience within a regulated medical device/clinical environment preferred; or equivalent combination of education and experience
Experience and Skills:
Required:
- English proficiency oral and written
- Must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
- Ability to use computers and computer-based software.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Preferred:
- Ability to communicate with affiliate in additional languages is an asset.
Other:
- Occasional travel will be required
