Post Market Surveillance Specialist

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Key Duties and Responsibilities

• GVP Tasks and Product Complaint Handling
  • Execute GVP activities in compliance with applicable GVP requirements, including adverse event reporting and field safety corrective action reporting.
  • Manage product complaints, including preparing investigation reports/letters for customers and coordinating with global teams.
  • Communicate and collaborate with Sales and Marketing teams regarding product complaints and customer issues.
  • Prepare and revise package inserts (J-IFU), including coordination and negotiations with PMDA and MHLW as required.
  • Conduct product risk assessments.
  • Serve as the primary contact for audits conducted by Japanese regulatory authorities and certification bodies, including PMDA, TMG, and Notified Bodies.
  • Conduct internal audits.

Education and Experience

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field preferred.
• At least 3 years of experience in post-market surveillance and GVP activities within the medical device industry.

Essential Skills and Abilities

• Strong communication and interpersonal skills.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Strong organizational and problem-solving skills with attention to detail.
• Knowledge of Japanese medical device regulations, including GVP and QMS Ordinance.

Competencies

• Business-level English communication skills (written and spoken)
• Computer skills – MS-Word, Excel, PowerPoint

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.