Job Description

BioTalent is partnered with an IVD medical device manufacturer to hire a QA/RA Director. This individual will oversee all aspects of quality assurance and regulatory affairs, working closely with cross-functional teams to drive compliance and continuous improvement initiatives.

Responsibilities :

1. Develop and implement quality assurance and regulatory strategies to support the company's goals and objectives.
2. Lead the QA/RA team in the establishment and maintenance of quality management system in accordance with applicable regulations and standards (13485, 14971, Part 820, etc).
3. Ensure compliance with regulatory requirements for product development, manufacturing, distribution, and post-market surveillance activities.
4. Manage regulatory submissions, including 510(k) premarket notifications, CE Mark applications, and international registrations, ensuring timely approvals and clearances.
5. Provide guidance and support to cross-functional teams on regulatory requirements, standards interpretation, and compliance strategies.
6. Conduct internal and external audits to assess compliance with regulatory requirements and QMS effectiveness, identifying areas for improvement and implementing corrective actions as needed.
7. Stay abreast of changes in regulations, standards, and industry trends, assessing their impact on the company's products and processes, and proactively addressing potential risks.
8. Collaborate with key stakeholders, including R&D, manufacturing, clinical affairs, and marketing, to ensure alignment of quality and regulatory objectives with business goals.
9. Represent the company during regulatory agency inspections and audits, serving as the primary point of contact and ensuring readiness and compliance.

Qualifications :

1. Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
2. Minimum of 8-10 years of experience in quality assurance and regulatory affairs within the medical device industry, with at least 5 years in a leadership role.
3. Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant international standards.
4. Proven track record of successful regulatory submissions and approvals for medical devices in major markets (e.g., US, EU, Canada).
5. Experience leading QMS implementation, maintenance, and improvement initiatives, including CAPA, change control, and risk management processes.

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