Dozee, a leader in the healthcare technology industry, is hiring for the position of Regulatory Affairs Associate in Bengaluru, Karnataka. Known for its innovative solutions in remote health monitoring, Dozee offers a dynamic work environment for individuals passionate about regulatory compliance in the medical device industry. This full-time, on-site role is ideal for those looking to contribute to cutting-edge healthcare technologies while ensuring adherence to global regulatory standards.
Job Responsibilities
As a Regulatory Affairs Associate at Dozee, your key responsibilities include:
- Regulatory Submission Strategy: Participate in developing strategies for regulatory submissions and approvals in various countries.
- Compliance Assurance: Ensure compliance with critical regulatory frameworks such as FDA, ISO 13485, MDR (Medical Device Regulation), and other relevant international standards.
- Regulatory Requirement Awareness: Stay updated on new and existing regulatory requirements and their impact on the company’s products and processes.
- Documentation and Submission Support: Assist in generating the required documentation for regulatory submissions and assemble regulatory submission packages.
- Audit and Inspection Support: Provide support during audits and inspections by regulatory authorities or notified bodies, ensuring all documentation is up to date and accessible.
- QMS Maintenance: Assist in the creation, revision, and maintenance of Quality Management System (QMS) documentation, ensuring it aligns with ISO 13485 requirements. This includes managing SOPs, work instructions, and forms.
- CAPA Administration: Help administer and track Corrective and Preventive Actions (CAPA) to resolve compliance issues.
- Continuous Improvement: Participate in initiatives aimed at improving the effectiveness of the QMS and overall regulatory processes.
Qualifications and Requirements
To excel in this role, the following qualifications are essential:
- Experience: 1-2 years of experience in Regulatory Affairs within the medical device industry is required.
- Regulatory Knowledge: Strong understanding of FDA regulations, ISO 13485, CDSCO (Central Drugs Standard Control Organization), and EU MDR (Medical Device Regulation) requirements.
- Attention to Detail: Ability to manage detailed regulatory submissions and work through complex regulatory documentation.
- Problem-Solving: Strong analytical and problem-solving skills to navigate regulatory challenges.
- Risk Management: Familiarity with risk management and clinical evaluation processes.
- Agency Interaction: Experience interacting with regulatory agencies during submission processes or audits.
How to Position Yourself for This Job
To position yourself as a strong candidate for this role:
- Highlight Relevant Experience: Emphasize your experience in regulatory submissions, especially within the medical device industry, and your knowledge of international regulatory standards (FDA, ISO 13485, EU MDR).
- Showcase QMS Knowledge: Mention your involvement in maintaining and improving Quality Management Systems, particularly in accordance with ISO 13485.
- Demonstrate Problem-Solving Skills: Provide examples of how you’ve handled regulatory challenges or audits, focusing on your analytical abilities.
- Understand Regulatory Updates: Stay informed about recent changes in regulatory frameworks that affect medical devices, and be ready to discuss how these impact the industry.
