Regulatory Affairs Manager - South Korea at Hologic, Inc.

, , North Korea -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, IVD, Korean Medical Devices Act, Quality Management Systems, ISO 13485, ISO 9001, Regulatory Strategy, Risk Management, MFDS Audits, EU MDR, IVDR, FDA Regulatory Pathways, People Management, Stakeholder Management, Strategic Planning

Industry

Medical Equipment Manufacturing

Description

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 cross‑functionally 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 problem‑solving 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! #LI-RH1

Responsibilities

The Regulatory Affairs Manager oversees the development and implementation of regulatory strategies to ensure product compliance and market access in South Korea. This role leads a team and collaborates cross-functionally to maintain quality management systems and manage interactions with regulatory authorities.