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Regulatory Compliance Specialist

2 months ago

Woburn, Massachusetts, United States Biofrontera Full time
Job Overview

Position Summary

The Regulatory Compliance Specialist plays a crucial role in evaluating and interpreting data essential for both internal processes and external disclosures. This position is tasked with implementing measures to uncover and address any activities that may not align with relevant laws, industry standards, and internal policies applicable to pharmaceutical and medical device organizations. Staying informed about evolving regulations is vital, as is the ability to suggest modifications and enhance compliance training initiatives.

Key Responsibilities

  • Conduct thorough audits of documentation to ensure adherence to relevant laws, regulations, company protocols, and industry standards. Maintain comprehensive records of audit activities and outcomes; generate monthly reports for assessment.
  • Compile necessary documentation for all federal and state Sunshine reports along with associated healthcare compliance obligations. Review and authorize all expense submissions.
  • Detect and swiftly report any potential non-compliant activities. Prepare detailed summaries of identified issues along with supporting documentation for evaluation.
  • Assist in the regular review of policies and procedures governing business practices and compliance training programs for both new and existing personnel; recommend necessary adjustments.
  • Engage in and contribute to compliance training sessions for both new hires and current employees.
  • Oversee the business integrity hotline for anonymous reporting of compliance issues and conduct or facilitate investigations as needed.
  • Stay updated on compliance trends and collaborate with management to provide effective business solutions that ensure Biofrontera's compliance in a dynamic regulatory environment.
  • Perform additional duties as assigned.

Required Qualifications and Experience:

  • Bachelor's degree is mandatory.
  • A minimum of 5 years of experience in a healthcare or corporate compliance role within the biotech/pharmaceutical/device sector.
  • Proven understanding of federal and state regulations and industry standards impacting the biotech/pharmaceutical/device sector, particularly in relation to Sales and Promotion.
  • Prior experience in auditing is essential.
  • Proficient in O365 and web-based data reporting tools.

Essential Attributes:

  • Ability to work independently while managing detailed information.
  • Excellent interpersonal, collaborative, and communication skills.
  • Strong focus on deadlines and attention to detail.

Direct Reports:

  • This position does not have any direct reports.