Regulatory Compliance Manager
1 week ago
Arjo Inc. is seeking a seasoned Regulatory Compliance Manager to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to mitigate risk.
The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience in managing cross-functional teams and developing training programs.
Key Responsibilities:
- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct internal audits and provide recommendations for improvement.
- Collaborate with internal stakeholders to develop training programs and materials.
- Manage relationships with regulatory agencies and industry partners.
- Provide guidance on regulatory requirements and best practices.
Requirements:
- Bachelor degree in a STEM field required (other degrees will be considered if quality experience is relevant to the role); Master's degree preferred.
- Must have 5+ years of prior experience in industry-related regulatory systems management.
- Thorough knowledge of applicable procedures and regulations of 21 CDR 803, 806, 820 FDA, Health Canada, ISO 13485/MDSAP.
- Excellent communication and interpersonal skills.
- Ability to travel up to 25% of the time.
Estimated Salary: $100,000 - $130,000 per year.
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