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Regulatory Risk & Compliance Consultant (Manufacturing)

Hire Score LLC
Posted Apr 12
Contract
New Jersey

Position Overview: The purpose of the Regulatory Risk and Compliance Consultant role is to ensure efficient and compliant operations from manufacturing to delivery. Accordingly, you will be responsible for designing processes and strategies to ensure compliance with all relevant regulatory requirements of sales contracts and for identifying, assessing, and mitigating risks associated with non-compliance.

Key Responsibilities:

Regulatory Compliance:

  • Stay informed and educate the ELT and sales teams on relevant laws, regulations, and industry standards applicable to the packaging/display industry.
  • Take a proactive approach to understanding client contracts and required deliverables ensuring products meet quality standards.
  • Design the process for monitoring compliance, including internal audit and spot check processes to mitigate risks of non-compliance.

Corporate Compliance Policy Development:

  • Develop and update corporate compliance policies and procedures to align with legal requirements, ethical standards, and regulations set by agencies such as OSHA and the EPA.

Vendor Compliance Policy Development:

  • Develop and update vendor (Third-Party manufacturer) compliance policies and procedures to align with industry-specific packaging regulations and manufacturing standards applicable to the company’s customer ecosystem such as FDA, EPA, OSHA, or similar global standards.
  • Define monitoring and auditing strategies of vendor manufacturing practices to identify potential compliance issues and implement corrective actions, ensuring compliance by vendors.
  • Develop and implement risk management framework for conducting comprehensive risk assessments to identify operational, financial, and reputational risks.
  • Build a training strategy to ensure that employees understand customers’ compliance policies and ensure selected suppliers are producing products in compliance with customers’ required specifications.

Reporting and Documentation process:

  • Design and implement process for maintaining accurate records of compliance activities, including audits, training sessions, and incidents of non-compliance. Prepare compliance reports for internal and external stakeholders.
  • Work closely with the company’s legal team, suppliers, external auditors, regulatory bodies, and internal departments to ensure compliance policies are being followed and corrective actions are being taken.

Qualifications and experience:

  • Bachelor’s degree in law, Business Administration, Engineering, or a related field. Advanced degrees or certifications (e.g., Certified Compliance & Ethics Professional) are highly regarded.
  • Proven experience in regulatory compliance, risk management, quality, or a related field, preferably within the manufacturing industry.
  • Understanding of industry-specific packaging regulations and manufacturing standards, specifically FDA, EPA, and GMP strongly preferred.
  • Familiarity with quality management systems such as ISO 9001, ISO 1400, and/or AS9100

Skills and Competencies:

  • Strong knowledge of regulatory requirements, excellent analytical and problem-solving skills, and the ability to communicate effectively with various stakeholders
  • Detail-oriented, proactive, and able to work independently as well as part of a team.