Regulatory Compliance Specialist

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 assure local and national requirements are met.

Key Responsibilities

• Independently review/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 accumulate necessary potential complaint information.
• Review service calls, material returns, phone logs and other sources of customer feedback for potential customer complaints.
• Monitor the status and progression of complaints under investigation and monitor the Complaint Product Return Goods process for efficiency and effectiveness, providing feedback concerning areas of deficiency.
• Provide detailed Complaint Database reports and/or Complaint status information for management review and as requested.
• Assist with coordinating activities pertaining to proactively addressing emerging and potential customer issues in the USA. Interface directly with the customer by providing written and/or verbal responses to complaints.
• Assist in determining, developing and implementing policies/procedures for appropriate, comprehensive and effective quality system and regulatory compliance.
• Manage other tasks in support of Draeger’s vigilance system and performs other duties as needed and assigned.

• Associates degree or equivalent experience required.
• 3-5 years’ experience in a medical device company, preferably in a Regulatory or Quality related role.
• Strong working knowledge of MS Office (Outlook, Word, Excel & PowerPoint).
• Experience using TrackWise, CRM and/or SAP a plus.
• Excellent communication skills both written and verbal.

Benefits

Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home. We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4 weeks per year, tuition reimbursement, 401k match, wellness and employee support programs, life insurance and more. Dräger also offers localized perks such as free parking and onsite gym with fitness instructors and classes, full-service cafeteria, and game room at select locations.

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

Our field based Sales and Service workforce is located across the nation, caring for relationships with our customers in the delivery of Draeger’s exceptional portfolio of products and solutions.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.