Job description

Local candidates needed to sit on site in a Hybrid Model: 2 days in office (TBD which days), 3 days working from home.

KEYS- Bach Deg in Biomedical or Nursing (MUST), any complaint handling/customer service is a BIG PLUS. Strong MDR documentation or technical writing experience. Must have excellent computer skills
Looking for Engineers (biomedical engineers, mechanical engineers), health care professionals (nurses), but will review other educational backgrounds as well.
Top 3 skills:

• Strong attention to detail
• Strong communication skills
• Capable of handling changes to process

In this exciting role as an MDR/Vigilance Specialist you will have responsibility for:

• Facilitate complaint communications and assess for regulatory reportability and potential impact to patient safety and business operations.
• Complete and submit regulatory reports within the timeframes mandated by the FDA.
• Solid knowledge in clinical settings related to product application. Evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Develop internal systems, methods, and procedures to maintain compliance and support post-market surveillance. Evaluate and recommend changes to current systems. Serve on multi-business teams to evaluate system changes/upgrades.
• Receive and document product events reported by customers and field representatives. Request additional information as needed for complete understanding of the event. Determine if event is a product complaint.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

Job Types: Full-time, Contract

Pay: $25.00 - $28.00 per hour

Shift:

• Day shift

Weekly day range:

• Monday to Friday

Work setting:

• In-person

People with a criminal record are encouraged to apply

Education:

• Bachelor's (Required)

Work Location: In person

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