Remediation Specialist

1. Create/ Update design history file documents such as Requirement documents, Design input / output, Verification & Validation, Traceability & Risk management documents

(DFMEA, PFMEA, UFMEA, PHA, RMP, RMR etc. )

1. DHF gap Assessment and remediation for latest medical device standards (FDA 21 CFR Part 820, EU MDR etc)
2. Update/ Create process and product qualification documentation includes IQ/OQ/PQ, Test method validation, Gauge R&R & PPAP process.
3. Identifying gaps and remediate sterilization and bio compatibility documentation for medical devices.
4. Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
5. Understanding and complying with regulatory standards for medical devices including regional regulatory requirements.
6. Knowledge of ISO13485 medical device quality management system and ISO 14971 medical device risk management process.
7. Manage the design history file and originate / review the documents in product life cycle management tools like Agile/ Windchill.

Desired Skills and Qualifications:

1. Bachelor / Diploma in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
2. 4-8 years of experience in Medical device industry specialized in product development/design quality/ remediation process
3. Excellent communication, with the ability to work effectively with cross-functional teams.
4. Strong understanding of technical documentation requirements for medical devices (e. g. , design controls, risk management, QMS).

Additional Responsibilities:

1. Stay current on industry trends: Attend industry conferences, webinars, and workshops to stay informed about emerging trends, policies, and laws in the medical device industry.
2. Collaborate with cross-functional teams: Work closely with other departments, such as quality assurance, manufacturing, and clinical affairs, to ensure a comprehensive understanding of product development and regulatory requirements.