
Regulatory Compliance Specialist
1 day ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our team.
Job DescriptionThe successful candidate will be responsible for coordinating the preparation and submission of regulatory documents, maintaining effective working relationships with regulatory authorities and internal stakeholders, and ensuring compliance with relevant regulations and guidelines.
Key Responsibilities:- Document Coordination: Collaborate with internal teams to obtain essential documents required by regulatory authorities during the registration process.
- Relationship Management: Establish and maintain positive working relationships with regulatory authorities and internal peers to ensure timely support and document preparation.
To succeed in this role, you will require:
- A bachelor's degree in a related field, such as healthcare, medical, or engineering.
- Basic understanding of ISO 13485 and US FDA regulations related to medical devices.
- Minimum of 2 years of relevant experience in regulatory and quality assurance roles.
This is an excellent opportunity to develop your career in regulatory compliance and work in a dynamic and fast-paced environment.
Other RequirementsAs a successful candidate, you will possess:
- Strong attention to detail and organizational skills.
- Excellent communication and interpersonal skills.
- Ability to motivate others and take ownership of projects.
- High ethical standards and integrity.
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