We have an opening with a Class III medical device company who is ramping up commercialization in the US market. They are looking for a Director of Compliance to build their overall Compliance Program from the ground up.
This company has been implanting cardiac focused devices for over 15 years outside the US, they received FDA approval earlier this year and have successfully conducted their first US implant.
They are right now ramping up for a period of incredible growth in a market worth tens of billions of dollars.
Initial priority for this position will be on the Commercialization Team focusing on sales and marketing activities.
Their pipeline is robust with new products planned over the next four years.
This is an excellent opportunity for someone to build a program and grow with this organization. I am happy to answer questions and provide more details.
- Develop a Compliance Program from the ground up
- Create internal compliance training program
- Implement a compliance monitoring and audit program
- Establish a Company-wide compliance operating committee to drive compliance initiatives
- Ensure compliance with HIPAA, GDPR, and other privacy regulations.
- Establish a marketing review protocol to ensure materials are within FDA/ labeling requirements
- Establish compliance reporting for complaints
- Provide internal guidance on compliance related questions and concerns that come up within the organization, with initial focus on sales and marketing functions.
- Looking for 8 years of Healthcare related Compliance experience with at least 4 years in medical device.
- Juris doctorate degree required
- Position based in PA/NJ/DE region.
Job Type: Full-time
Salary: $150,000.00 to $200,000.00 /year
Work authorization:
- United States (Required)
Additional Compensation:
- Bonuses
Work Location:
- One location
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Relocation assistance
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