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Healthcare Compliance Director

Exton, PA
Job Description: 

Compliance Director

Compensation Package:        
Base Salary: $140,000 - $160,000      
Bonus Potential: 20% of Base Salary
401k Option: Company also provides a up to matching contribution option                                   
Healthcare Benefit Options: Medical, Dental, Vision, Flexible Spending Account and Dependent 
Care Insurance: Life and Disability Insurance                         
Paid Time Off: Vacation and Sick paid days off are available
Expense Information: Company pays for all business-related expenses (compliance regulations apply)
Location: Must live within 90 miles of Philadelphia (Must work inside corporate office at minimum 1 day per week) 

Job Description          
The Compliance Director reports directly to the CEO and is part of the executive leadership team. This position ensures company conducts its business in compliance with all laws and regulations that relate to the healthcare industry, in addition to professional, external, and internal standards along with accepted business practices.

This position leads and manages all legal and ethical compliance processes at our company and is responsible for working in partnership with internal stakeholders and business partners along with providing strategic direction on commercial programs, initiatives and processes that have compliance consequences.
Responsibilities include establishment, further development, and maintenance of Compliance procedures and processes for the following:
  1. Healthcare
  2. Sunshine Act
  3. HIPAA
  4. Advamed, including Code of Ethics
  5. Other
  6. SOX
  7. OSHA
  8. Data Protection
  9. Other Legal Compliance laws and regulations 

The Compliance Director is responsible for the compliance review of materials, policies, and plans in areas such as applicable regulations and standards, field sales and non-field sales training documentation and processes, compensation programs, internal and external education materials, sales and marketing documentation, internal and external communications, etc.  

Key Success Indicators:
  • Assure compliance with applicable laws, regulations, and standards.
  • Liaise and coordinate compliance activities with external and internal stakeholders
  • Work with company leadership to develop, monitor, and measure compliance processes
  • Establish and maintain compliance procedures
  • Ensure critical business processes are compliant
  • Lead the development and standardization of a compliance culture
  • Work with company leadership to develop, monitor, and measure compliance goals and objectives
  • Conduct annual compliance audits/reviews of critical business processes and issue reports
  • Develop and lead the compliance investigation process
  • Work with company leaders to ensure the compliance program is effective and continually improved
  • With department managers, identify and implement internal compliance controls required for business critical process
  • Strong knowledge of laws, regulations, and standards applicable to the healthcare and medical device industry including those applicable to sales and marketing promotion, privacy, and anti-bribery
  • Identify compliance gaps and work with management in business critical processes to resolve in line with best business practices
  • Retain a health and safety schedule; recording annual checks, management and review of incident reports
  • Monitor changes to legislation and implement business wide
  • Conduct health and safety inductions and training for staff, contractors and visitors, as required
  • Conduct facility walk through and perform business area risk assessments
  • Implement corrective and/or preventative action on identified potential hazards
  • Maintain accident and incident reporting register 
  • Bachelor’s Degree in Engineering, Life Science, Business, Marketing or related study is preferred
  • A minimum of 10 years’ experience in Compliance or related field is desired
  • A minimum of five years of experience working in a highly-regulated regulatory environment in Engineering, Life Science, Quality, Sales, Marketing or related field is preferred
  • Demonstrated experience with a Oracle and/or SAP system is preferred (e.g. Cebos EQMS)
  • Strong Microsoft Office skills in Word, Excel and Outlook
  • Must have experience within the medical device or disposable space
  • Must complete a successful background check and drug screening
  • Must have a valid Driver’s License
  • Legally authorized to work permanently in the U.S. and not require sponsorship for employment visa status now or in the future
LEE WEBER GROUP--Placing you in a Better Future
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Office: 859-296-1112
Email: mail@leewebergroup.com
Fax: 859-296-0050
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