Welcome to Beckman Coulter, a leading medical technology company dedicated to advancing healthcare for patients around the world. We are seeking a highly skilled and detail-oriented PMS (Post-Market Surveillance) Specialist, Regulatory Affairs Compliance to join our team. As the PMS Specialist, you will play a critical role in ensuring that our products comply with all regulatory requirements and post-market surveillance activities. The ideal candidate will have a strong background in regulatory affairs, a keen eye for detail, and a passion for improving the lives of patients. Join us in our mission to make a difference in the world of healthcare.
Conduct thorough and timely post-market surveillance activities in accordance with regulatory requirements.
Monitor and analyze post-market data and trends to identify potential product issues and escalate to appropriate teams.
Maintain up-to-date knowledge of relevant regulations and guidelines related to post-market surveillance and report any changes or updates to the team.
Develop and maintain procedures and processes for post-market surveillance activities.
Collaborate with cross-functional teams to ensure timely and accurate completion of post-market surveillance tasks.
Participate in internal and external audits to ensure compliance with regulatory requirements.
Prepare and submit post-market surveillance reports to regulatory agencies as required.
Communicate with internal and external stakeholders regarding post-market surveillance activities and findings.
Review and assess complaints and adverse events related to products and escalate as necessary.
Provide support and guidance to other departments regarding post-market surveillance requirements and activities.
Maintain accurate and organized documentation of all post-market surveillance activities.
Proactively identify areas for process improvement and implement solutions to enhance efficiency and effectiveness of post-market surveillance activities.
Participate in product development and design control activities to ensure post-market surveillance requirements are considered.
Stay current on industry trends and best practices related to post-market surveillance and incorporate into processes and procedures.
Uphold company values and ensure compliance with all company and industry regulations and standards.
Where is this job?
This job is located at Shanghai, China
Job Qualifications
Bachelor’s Degree In A Scientific Field Such As Biology, Chemistry, Or Pharmacy.
Minimum Of 3 Years Of Experience In Regulatory Affairs Compliance, With A Focus On Medical Devices.
In-Depth Knowledge Of Fda Regulations And Guidelines, Including 21 Cfr Part 820 And Iso 13485.
Experience With Medical Device Submissions, Including 510(K) And Pma.
Strong Attention To Detail And Ability To Interpret Complex Regulatory Requirements.
Required Skills
Quality Assurance
Quality
Auditing
Change Control
Risk Assessment
Regulatory Compliance
FDA Regulations
Documentation Management
SOP Development
Product Registration
Labeling Requirements
Global Submissions
Soft Skills
Communication
Conflict Resolution
Leadership
Time Management
Interpersonal Skills
Creativity
Flexibility
Teamwork
Adaptability
Problem-Solving
