The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Location: Corporate officed based near West Chester, PA
Subject: Seeking experienced Compliance Director with JD or paralegal background to work for a growing orthopedic device company.
Salary/Compensation: Competitive salary and benefits relative to industry-leading medical device companies.
The Compliance Director ensures the 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 the 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:
Advamed, including Code of Ethics
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 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
Additional Salary Information: 30% bonus
Internal Number: orthocompliance
About Lee Weber Group, Inc.
The Lee Weber Group has quickly become a nationally regarded leader in Executive Healthcare Recruiting, and completely focuses on the medical and biotechnology industries. The group has successfully filled positions from coast to coast, and has an extensive database of healthcare professionals and industry-related information. The group takes pride in finding the right person for the right job at the right time, and works tirelessly to match the most qualified candidates to positions that maximize use of their skills and abilities.
Lee Weber is a results-driven, energetic, medical device industry business executive with a proven track record of successful sales management acquired in world-class companies when he was Director of Sales for both Johnson & Johnson Wound Management and Smith & Nephew United. In those previous sales leadership roles, Lee built top-class sales organizations, increased sales revenues, acquired market share and maximized market opportunities in various market spaces.
Specialties: Medical Recruiting, Medical Sales, Sales Management, Marketing, Clinical Staff, Executive, and Service related positions with various companies in the Disposables, Surgical, and Pharmaceutical Industries.