RAQA Manager/ Senior Manager

It’s a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.

We are hiring

APAC RAQA Manager / Senior Manager – Japan, Korea & Taiwan

Location: Remote – South Korea or Taiwan

As our APAC RAQA Manager / Senior Manager, you will take ownership of regulatory activities across Japan, South Korea and Taiwan, with a particular focus on supporting new product introductions and market expansion in Japan.

You will work closely with our Global Regulatory Affairs team, external regulatory partners and cross-functional stakeholders to ensure regulatory compliance, successful product registrations and continued market access. In addition, you will support the coordination of regulatory change management and regulatory intelligence activities across the APAC region.

Your strength

• Lead regulatory strategies, product registrations, renewals and lifecycle management activities across Japan, South Korea and Taiwan, with a strong focus on Japan.
• Develop regulatory submission strategies, timelines and market-specific requirements to support new product introductions and business growth.
• Assess the regulatory impact of product, manufacturing, supplier, labeling and other relevant changes, ensuring appropriate local regulatory actions.
• Coordinate APAC regulatory change management activities, working closely with local market owners and Global Regulatory Affairs.
• Monitor regulatory developments and coordinate regulatory intelligence activities across the APAC region.
• Manage relationships with external regulatory consultants, Japan DMAHs, local licence holders and other regulatory partners.
• Strengthen internal regulatory knowledge and reduce dependency on external regulatory resources.
• Collaborate with Quality, R&D, Clinical, Manufacturing, Supply Chain and Commercial teams to ensure compliant product launches and continued market access.
• Maintain accurate regulatory documentation, proactively identify regulatory risks and support continuous process improvements.

Your profile

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Biomedical Sciences or a related field.
• Approximately 8–12+ years of Regulatory Affairs experience within the medical device industry, with flexibility depending on demonstrated expertise.
• Strong hands-on experience in medical device registrations, regulatory submissions, product lifecycle management and regulatory change assessments.
• Regulatory experience in at least one of Japan, South Korea or Taiwan, with substantial knowledge of Japanese medical device regulations strongly preferred.
• Familiarity with Japan PMDA/MHLW requirements, Korea MFDS and/or Taiwan TFDA regulations.
• Experience collaborating with external regulatory consultants, local licence holders or distributors.
• Experience working with global regulatory teams and technical documentation within an international organization.
• Experience with high-risk or implantable medical devices, particularly cardiovascular, vascular or structural-heart products, is a strong advantage.
• Experience coordinating regulatory activities across multiple APAC markets is desirable.
• Strong stakeholder management, communication and organizational skills, with the ability to work independently in an international, remote environment.
• Excellent written and spoken English; Japanese, Korean or Mandarin language skills are an advantage.

Our strength

• A meaningful role within a global medical technology company dedicated to saving patients' lives.
• The opportunity to contribute to innovative medical devices and support business growth across key APAC markets.
• A collaborative and international working environment with close interaction across regional and global teams.
• A high level of autonomy, responsibility and opportunities to influence regulatory strategy and processes.
• Professional development opportunities and the chance to strengthen regulatory capabilities across the region.
• Flexible remote working arrangements, with international travel as required.

Join Artivion and contribute your expertise to helping us save lives. We look forward to receiving your application!

Brian Russo, T: +41 435 08 39 01

JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc.,

Lotzenäcker 23, 72379 Hechingen

www.artivion.com