Regulatory Compliance Specialist
We are seeking a highly organized and detail-oriented Regulatory Compliance Specialist to join our team. This is a dynamic opportunity for an individual with strong administrative skills to support our regulatory staff in maintaining compliance with industry regulations.
The ideal candidate will have excellent communication skills, both written and verbal, and be able to work effectively in a fast-paced environment. They will be responsible for providing administrative support to the regulatory team, managing files and documents, and performing data entry tasks.
This role requires a high level of organization and attention to detail, as well as the ability to prioritize tasks and manage competing deadlines. The successful candidate will be able to work independently and as part of a team, and will be committed to delivering high-quality results.
Key Responsibilities:
* Administrative Support:
* Provide administrative support to the regulatory team, including filing and tracking documents
* Manage files and maintain accurate records
* Perform data entry tasks and prepare reports
* Regulatory Compliance:
* Maintain compliance with industry regulations, including FDA 21CFR820 and ISO 13485
* Develop and implement procedures to ensure compliance
* Communication:
* Communicate effectively with internal and external stakeholders, including clients and vendors
Requirements:
* Bachelor's degree in a relevant field, such as science, engineering, or quality assurance
* Minimum 1 year of experience working in a quality assurance regulated medical product environment
* Thorough knowledge of regulatory requirements, including FDA 21CFR820 and ISO 13485
* Strong interpersonal skills and excellent communication skills
* Ability to prioritize tasks and manage competing deadlines