Compliance Officer
3 weeks ago
Job Summary:
Planet Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing consultation and advice to our regulatory specialists on change control and product development.
Key Responsibilities:
- Provide regulatory direction and interpretation on team activities to ensure compliance with relevant regulations and standards.
- Interpret and apply regulatory understanding to support products and teams, ensuring that all activities are aligned with company policies and procedures.
- Prepare and submit regulatory documents and submissions to government agencies worldwide, ensuring timely and accurate delivery.
- Handle regulatory activities involved in documentation, labeling, and field support, ensuring that all activities are compliant with relevant regulations and standards.
- Apply regulatory and technical knowledge to a wide variety of complex work assignments, ensuring that all activities are aligned with company policies and procedures.
- Maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
- Ensure compliance to and demonstrate knowledge of site and division level policies and procedures.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Support manufacturing/operations day-to-day activities for change control, ensuring that all activities are compliant with relevant regulations and standards.
Requirements:
- 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically with a quality, product-development/support, or scientific affairs function.
Preferred Qualifications:
- Knowledge of regulations and standards affecting IVDs and/or biologics.
Education:
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
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