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Product Safety Manager - Regulated Applications - Food Contact Job


Location: 

King of Prussia, PA, United States

Employment Type:  Regular
Category:  Regulatory Affairs
Posting Date:  May 10, 2022

Reports to Director of Product Safety & Regulatory Affairs and has one direct report.

 

Key activities and responsibilities:

  • Provide sound technical solutions to regulated application (ex. FDA, USDA, Health Canada (HC) DEA, Mercosur, and FIFRA) compliance issues by maintaining a working knowledge of related regulations, and adapting to changes in the regulatory environment, specific state requirements, or unclear or inconsistent interpretations by governmental agencies. 20%
  • Evaluate the impact of new legislation or rulemaking for Americas regulated applications (ex. FDA, Mercosur, USDA, HC, DEA, FIFRA) materials on the company’s diverse product lines and processes, coordinate comment within the company regarding those issues, and provide compliance guidance. 15%
  • Suggest and implement cost effective solutions to Americas regulated application (ex. FDA, Mercosur, USDA, HC, DEA, and FIFRA) regulatory compliance issues while maintaining a favorable business environment. 20%
  • Support Americas regulated applications good manufacturing practices at appropriate manufacturing facilities, including providing regulatory guidance and conducting audits. 10%
  • Negotiate sensitive issues for Americas regulated applications (ex. FDA, Mercosur, USDA, HC, DEA, and FIFRA) with governmental agencies or certification authorities while avoiding penalties or business interruption. 10%
  • Provide guidance on Americas regulated markets requirements and manage consultants and project budgets 10%
  • Direct, train, motivate and manage product safety regulatory specialist who supports regulated applications (e.g., FDA, USDA, HC, DEA, and FIFRA) 15%

 

Context & Environment

  • Ensuring that the Company’s products comply with product regulatory requirements in global inventories and food, drug, medical, and pesticide markets is challenging and complex. Compliance with product Americas regulated applications regulations (such as FDA, Mercosur, USDA, FIFRA, etc.) can be difficult since such regulations often driven by the intended end use and marketing claims and require controls over the manufacturing processes and distribution. If product regulatory compliance issues are not managed appropriately, the Company can be exposed to excessive expenditures and/or legal liability or be unable to sell its products. To achieve this, position must be able to define and carry out practical technical and strategic approaches that are dynamic and integrated with sound business management principles, fiscal responsibility, risk management techniques, and communications procedures.
  • Supports the site HES policy and complies with all regulatory and internal requirements.
  • Participates in HES activities provided by site management and Arkema Inc(e.g., Behavioral Base Safety, SafeStart, etc.).
  • Supports and promotes the reporting of all health, safety, environmental, near-miss, accident or injury incidents.

 

Required Education/Qualifications/Work Experience

  • Bachelors or Master’s degree in Chemistry or related science and minimum 15 years industrial experience.
  • Excellent understanding of US laws and regulations pertaining to regulated applications -- particularly FDA, USDAHC, DEA, Mercosur, and FIFRA applications.
  • Strong understanding of international counterparts to US food contact, medical device, and pesticide product laws and regulations, particularly in the Americas.
  • Strong project management skills and ability to coordinate teams from different countries and cultures
  • Advanced computer skills with standard office software and specialized programs highly desirable.
  • Knowledge of Latin American food regulations a plus.

 

Demonstrated Competencies

  • Excellent interpersonal, listening, communication and negotiating skills.
  • Ability to concurrently lead and/or manage multiple complex projects in a fast paced and complex environment.
  • Detail oriented, with excellent prioritization and follow-up.
  • Ability to challenge and influence decision making to diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc.
  • Self-directed with strong analytical and problem solving skills.
  • Ability to effectively navigate and work within in a global and culturally diverse environment.
  • Effective leadership capable of managing and developing subject matter experts


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