Manager, Regulatory Affairs & QA careers in Henry Schein at Pennsylvania, United States

Website Henry Schein

This Job listing For Year 2022 is about Henry Schein in Pennsylvania, United States

About the job


Regulatory Affairs

  • Responsible for maintaining compliance with all laws and regulations applicable to HSI business models and operations.
  • Develop and implement systems and procedures to research and monitor current regulations and new legislation at the Federal and State level.
  • Responsible for maintaining and enhancing the processes and systems in place for the receipt, storage and distribution of controlled substances, list 1 chemical.
  • Develop appropriate compliance awareness training programs and conduct training for different areas as needed.
  • Develop and implement systems and procedures to ensure compliance with Hazardous Materials, and OSHA requirements.
  • Ensure TSMs are appropriately trained to handle Hazardous materials in order to prepare safe domestic and international shipments of these products.
  • Develop and implement policies and procedures to ensure the safe storage and disposition of hazardous waste and ensure compliance with all applicable Environmental regulations.
  • Monitor changes to regulations, legislation, guidance documents and policy to determine impact to the Company and subsidiaries.
  • Oversee government inspection activities including inspectional observations as well as corrective action plans.
  • Interface with regulatory agencies (FDA, DEA, State BOP, DOT, OSHA, EPA, etc.) and review/approve changes to company policies and procedures.
  • Oversee the activities to secure and maintain proper company licensure and product registration as needed to supports HSI Operations and Business Units.
  • Coordinate and/or Conduct routine Regulatory audits and training in all Henry Schein facilities, affiliates and subsidiaries.
  • Assist on ensuring companywide regulatory compliance by supporting the infrastructure groups as well as the international and domestic business units.
  • Assist with and participate in a variety of quality and regulatory projects as required.
  • Provide ongoing direction to the team and provide development opportunities as needed.
  • Select, develop, and evaluate TSMs to ensure the efficient operation of the department.

Quality Assurance

  • Manage technical quality assurance audit activities.
  • Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.
  • Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.
  • Oversee suppliers to assure the quality of their products, materials, components and/or operations.
  • Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process.
  • Stay current with new or potential business opportunities, and prepare for all QA activities.
  • Research applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements).
  • Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed.
  • Select, develop, and evaluate TSMs to ensure the efficient operation of the department.


  • Knowledge of ISO 9001 and 13485 certification and maintenance and related FDA requirements.
  • Experience within the medical device and/or pharmaceutical industries.
  • Deep knowledge and understanding of regulations and guidance governing medical device manufacturing and/or healthcare distribution.
  • General knowledge of surrounding areas including DEA and FDA regulations, Good Manufacturing Practices, Hazmat management requirements, environmental regulations and ISO 9000.
  • Strong understanding of manufacturing and/or distribution and auditing processes.


  • Attract, retain, motivate, coach and develop team members for high performance.
  • Broad and wide-range of professional and managerial skills with a full understanding of industry practices and company policies and procedures.
  • Use skills to lead teams to achieve company goals in creative and effective ways.
  • Excellent planning/ organizational skills and techniques.
  • Excellent analysis and problem solving skills.
  • Excellent decision making skills.
  • Excellent negotiating skills.
  • Excellent writing and communication skills.
  • Ability to lead virtual teams.
  • Communicate effectively with senior management and key stakeholders.
  • Ability to Influence, build relationships, navigate politics and manage conflicts.
  • Understand, interpret and act on financial information that contributes to business profitability.
  • Ability to plan and manage successful projects, manage risks, costs, time and project teams.


Typically 7 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of management experience.


Bachelor’s Degree or global equivalent in Social Sciences or Science and Technology related technical disciplines. Master’s degree or global equivalent preferred.


  • Depending on specific area of responsibilities typically 10% to 40%
  • Office environment. No special physical demands required.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

For more information about career opportunities at Henry Schein, please visit our website at:

Company: Henry Schein

Vacancy Type: Full-time · Mid-Senior level

Job Location: Pennsylvania, United States

Application Deadline: N/A

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