Regulatory / Quality Assurance (Senior Executive / Associate Manager)

Tips : Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Responsibilities

• Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017 / 745, and 21 CFR part 820).
• Participate in development of Regulatory Strategy for upcoming products against GSPR requirements.
• Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System.
• Sustain and active Quality Management System, such as Management Review, Internal Audit, CAPAs, NCRs, Document Control, Change Control, Risk Management and Training.
• Participate and assist for establishment, verification, and implementation of Standard Operating Procedures to comply with a regulatory requirement.
• To maintain awareness of new legislation, policies, standards, and guidelines impacting Merlin’s products and Quality Management System. Update the relevant standard, regulatory guideline, and essential requirement.
• Participate and assist for regulatory submitting and reporting compliance with the requirements and relevant standard or guidance.
• Assist in the compliance of Validation / Verification Program and Design and Engineering studies.
• Promote audit readiness, prepare Merlin’s team for audits by external bodies, including NB, FDA, and facilitate audits as needed. Interface with inspectors, and NB auditors during inspections and provide post-inspection follow-up information as requested.
• Manage day to day execution of the quality system, and quality assurance activities facilitate and implements improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards.

Secondary Job Responsibilities :

Minimum Education Required :

Bachelor’s degree in life sciences, engineering, or equivalent

(life sciences post graduate, engineering, or equivalent with 10  years experiences)

Additional Qualifications Required :

ISO 13485, ISO14971, US FDA 21 CFR part 820 certification

MDR 2017 / 745 Medical Device requirement certification

Sterilization process certificate

Biocompatibility of medical devices Certification

Minimum Experience :

Minimum 10  years of related experience in the medical device