🔎 Title: Regulatory Affairs Contractor – PMDA Submissions

📍 Location: Onsite / Tokyo, Japan

⌛ Contract length: Minimum 9 months

✉️ Contact: [email protected]

🔸 The company

A global medical device company is seeking to strengthen its regulatory capabilities in Japan. This company is a well-established leader in innovative technologies and patient-centric solutions, operating across numerous therapeutic areas. With ongoing product expansion in the Japanese market, they are seeking regulatory expertise to support PMDA interactions and ensure smooth and compliant market access.

🔹 The Opportunity

We are supporting a confidential client to hire a Regulatory Affairs Contractor to lead and execute regulatory submissions to the PMDA for a portfolio of medical devices. This is a critical, high-impact role for a Japanese-speaking RA expert looking to work closely with local and global teams in a mission-driven environment.

Key responsibilities:

• Prepare, coordinate, and submit regulatory dossiers to the PMDA.
• Lead communication with PMDA and MHLW, managing queries and clarifications.
• Ensure all submissions are aligned with local regulatory requirements.
• Collaborate with global RA, quality, and clinical teams to align on technical content.
• Support other RA activities as required to meet business objectives.

🔹 Requirements

• Proven experience in Regulatory Affairs within the medical device or combination product sectors.
• Track record of successful PMDA submissions.
• Fluent in Japanese; moderate English proficiency (written and spoken).
• Strong understanding of the Japanese regulatory environment and documentation standards.
• Excellent organisational skills with the ability to work independently and meet deadlines.

🔹 Timelines

Start Date: ASAP

Initial contract: 9 months, with potential for extension

✉️ If you are interested in this exciting opportunity, please send your application directly to [email protected]

📲 Want to see more MedTech roles? Visit https://www.elemed.eu/vacancies/

🩺 Elemed is Europe’s leading MedTech technical recruiter. We partner with companies across Medical Devices, Diagnostics, and Combination Products, connecting them with top talent in Regulatory, Quality, Clinical, and R&D.

📣 Awarded Best International Recruitment Agency at the Recruiter Awards 2021.

At Elemed, we place exceptional people who solve regulatory and compliance challenges—so patients can access safe, innovative, and life-changing medical technologies.

⚖️ We are an equal opportunity employer and value diversity. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.