The Job Responsibilities
We're hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle "Technology for Life".
The Regulatory Compliance Specialist is a hybrid position (2 days in office) located at our North America headquarters in Telford, Pennsylvania.
The Regulatory Compliance Specialist is responsible for processing complaints and adverse events to ensure local and national requirements are met.
Key Responsibilities
* Independently review and evaluate customer complaints to determine and document Medical Device Reporting decisions in accordance with US FDA regulations.
* Work independently and/or interface directly with other Draeger functional departments, local subsidiaries, field service and clinical personnel, as well as customers to effectively gather necessary complaint information.
* Review service calls, material returns, phone logs, and other sources of customer feedback for potential complaints.
* Monitor the status and progression of complaints under investigation and oversee the Complaint Product Return Goods process for efficiency, providing feedback on areas of deficiency.
* Provide detailed Complaint Database reports and/or Complaint status updates for management review and as requested.
* Assist in coordinating activities to proactively address emerging and potential customer issues in the USA, including direct communication with customers regarding complaints.
* Assist in developing and implementing policies and procedures for effective quality system and regulatory compliance.
* Support Draeger's vigilance system and perform other duties as assigned.
Your Qualifications
* Associates degree or equivalent experience required.
* 3-5 years' experience in a medical device company, preferably in a Regulatory or Quality role.
* Strong knowledge of MS Office (Outlook, Word, Excel, PowerPoint).
* Experience with TrackWise, CRM, and/or SAP is a plus.
* Excellent written and verbal communication skills.
The Draeger Workplace
We prioritize employee health & wellbeing, offering comprehensive benefits such as medical, dental, and vision coverage, paid time off starting at 4+ weeks per year, tuition reimbursement, 401k match, wellness programs, life insurance, and more. Local perks include free parking, onsite gym, cafeteria, and game room at select locations.
Who we are
Draeger has multiple sites across North America, with our headquarters in Telford, PA. We also have locations in Andover, MA, Houston, TX, and Mississauga, Ontario. Our field-based sales and service teams support customers nationwide.
EEO is the Law
Draeger is an Equal Opportunity Employer. Learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)
We serve hospitals, fire departments, industrial clients, and more, providing cutting-edge technology built on over 130 years of experience and the dedication of over 16,000 employees, committed to turning technology into "Technology for Life".
Interested?
Please apply directly through our career portal. We look forward to receiving your application.
Apply now
Questions?
Contact Tracy Kohler at tracy.kohler@draeger.com.
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