Compliance Manager | BioNJ Talent Services

Compliance Manager

Contact Information
Contact Name: 
Human Resources
Organization Name: 
OrthogenRx, Inc.
Position Location: 
Doylestown, PA 18901
Email to Apply: 
hr@orthogenrx.com
Company Profile: 

OrthogenRx, Inc. (www.orthogenrx.com) is a medical device company focused on the development and commercialization of treatments for musculoskeletal conditions including osteoarthritis (OA). Our first commercial product is GenVisc® 850 (sodium hyaluronate)* indicated for the treatment of osteoarthritic knee pain.

OrthogenRx senior management has over 50 years’ experience in the biopharma industry and 30 years’ experience with the sales, marketing and reimbursement of products in the targeted class of medical devices. Board members and leading advisors include expertise in FDA law and regulations, reimbursement, emerging company management and investment, sales & marketing and mergers & acquisitions, as well nationally recognized law firms in intellectual property law and general corporate counsel, all contributing to a world class management and advisory team.

Established in 2014, OrthogenRx has grown to 30 employees in less than five years. The company is located in Doylestown, PA with easy access within Bucks County and from the surrounding PA and NJ counties.

Job Description:

This is an outstanding opportunity for a compliance professional to join a fast-paced, growing company and have a significant impact, both in monitoring and executing on the current compliance program. The ideal candidate will be detail oriented and meticulous, with excellent interpersonal skills and experience interacting with staff at all levels.

This position reports to the Vice President of Operations and Compliance. Responsibilities include:
• Overseeing, maintaining and monitoring the Compliance Program, making revisions as necessary
• Interfacing with legal counsel, external resources, management, departments and committees
• Serving as point of contact throughout the company for compliance issues
• Developing and delivering compliance training
• Maintaining audit schedules
• Investigating compliance violations
• Maintaining current knowledge of regulatory trends and changes in the law, and advising management of relevant trends
• Providing regular reports to senior management

Qualifications: 

QUALIFICATIONS
• Bachelor’s Degree
• Compliance certification preferred
• Three to five years of compliance experience in medical device, pharmaceuticals and/or healthcare
• Strong knowledge of industry standards and regulations
• Demonstrated business acumen, analytical skills, detail orientation and planning ability
• Excellent reporting and record keeping skills
• Comfort working in a small, fast-paced environment

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Compliance
Number of Openings: 
1
Paid: 
Yes
Relocation Package Offered?: 
Maybe