Regulatory Affairs Manager - South Korea

Regulatory Affairs Manager

The Regulatory Affairs (RA) Manager plays a critical role in contributing to Hologic's success by overseeing the development, implementation, and maintenance of regulatory strategies aligned with corporate objectives. This role leads a small regulatory team and collaborates crossfunctionally to achieve regulatory goals while ensuring the highest standards of compliance, product safety, and efficacy.

What To Expect:

Regulatory Strategy & Compliance

• Develop and execute regulatory strategies for product registrations, submissions, and approvals in compliance with local regulations and guidelines, including the Korean Medical Devices Act.
• Monitor and interpret changes in the regulatory environment and provide strategic guidance to internal stakeholders on potential impacts.
• Build and maintain strong relationships with regulatory authorities, industry associations, and relevant bodies to stay informed and ensure effective communication.
• Ensure commercial priorities are reflected in both local and global regulatory strategies by providing regulatory insights and market considerations.
• Perform additional duties and responsibilities as required by leadership.

Quality Management Systems

• Support the establishment and maintenance of a comprehensive Quality Management System (QMS) aligned with applicable standards and regulations, including ISO 9001, ISO 13485, and GDP.
• Provide guidance on the interpretation and implementation of regulations, guidelines, and standard operating procedures (SOPs).

Compliance & Risk Management

• Identify potential risks affecting regulatory strategies and product registration timelines, and develop mitigation plans.
• Ensure ongoing compliance with regulatory requirements through monitoring, documentation, and reporting.
• Lead investigations and resolution of regulatory issues.
• Facilitate and support MFDS regulatory audits.

Regulatory Intelligence & Advocacy

• Stay informed on changes to regulations, guidelines, and industry best practices.
• Conduct regulatory assessments for new regulations, technologies, and product lines to support market access strategies.
• Represent the company in industry forums, working groups, and regulatory meetings to advocate for company interests and contribute to policy discussions.
• Serve as an internal subject matter expert on regulatory and quality requirements.

What We Expect:

• In-depth understanding of the Korean medical device and IVD regulatory environment with the ability to execute regulatory activities accurately and on time.
• Strong knowledge of the Korean Medical Devices Act and relevant regulations.
• Working knowledge of EU MDR/IVDR and US FDA regulatory pathways (510(k) and PMA).
• Proven track record of successful product registrations, submissions, and approvals in the Korean market.
• Minimum of 10 years of regulatory affairs experience within the medical device or IVD industry.
• Experience working in multinational organizations, ideally US or European headquartered companies.
• Strong leadership and people management skills, with the ability to motivate and guide a small team.
• Strategic mindset with strong analytical and problemsolving abilities to navigate complex regulatory challenges.
• Excellent communication, collaboration, and stakeholder management skills.
• Highly organized with strong attention to detail and the ability to manage multiple projects and priorities simultaneously.
• Demonstrated success in establishing and maintaining relationships with regulatory authorities.
• Positive and proactive attitude.
• Excellent written and verbal communication skills in both Korean and English, with strong presentation abilities.

Why Hologic?

Thrive in an environment that fosters creativity and forward-thinking. Develop your skills and career in a company committed to your professional development. Apply now!

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