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Regulatory Affairs Professional
2 weeks ago
Job Description:
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with relevant regulations and guidelines.
Key Responsibilities:
- Support business operations for product registrations within the defined territory, ensuring timely and accurate submissions to regulatory authorities.
- Provide visibility and reporting of ongoing product registrations and their status to stakeholders using product registration trackers as required.
- Communicate expected product design changes received from manufacturers to distributors and authorities, collect information from distributors and authorities on their impact, and inform manufacturers and distributors on actions resulting from these changes.
- Clarify registration requirements to manufacturers when required, providing guidance on necessary documentation and procedures.
- Inform manufacturers of relevant expected regulatory changes and stay up-to-date with such changes in the defined territory, ensuring our products remain compliant with evolving regulations.
- Provide updates to management through regulatory intelligence gathered via commercial teams, distributors, and authorities in the designated territory, identifying areas for improvement and opportunities for growth.
- Collaborate with technical service teams in collating information on potential reportable events in the designated territory, ensuring prompt resolution and minimizing any potential impact.
- Submit files and interact directly with regulatory authorities; follow up closely with authorities until registration is finalized, demonstrating our commitment to compliance and customer satisfaction.
- Release shipments: assess import/export requirements for products, review and submit required documents, and follow up with competent authorities, including customs and other regulatory bodies.
Quality Assurance:
- Assist in tasks related to quality management system (QMS) implementation and ISO certification, as well as system upgrades whenever required within the office.
- Monitor and close out field corrective actions (FSCAs) in the affected designated territory, ensuring timely resolution and minimal disruption.
- Provide periodic updates of FSCA status to regulatory and quality directors and other stakeholders in the designated territory, maintaining transparency and open communication.
- Assist in product modification reporting and adverse event reporting to regulatory authorities within the defined territory as required, ensuring compliance with all applicable regulations.
Qualifications:
- Bachelor's degree in a related field such as life sciences, biomedical engineering, or medical technology.
- In-depth understanding of relevant regulations and guidelines, particularly those related to IVDs (In Vitro Diagnostic Medical Devices Regulation).
- Experience of ISO 13485 ensures compliance with standards as well as certificate maintenance.
- Minimum 3 years' work experience in regulatory affairs and quality assurance, preferably in MD/IVD Industry.
- Excellent written and verbal communication skills essential for interaction with regulatory authorities and cross-functional teams.
