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.<\/p>\n
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Conduct thorough and timely post-market surveillance activities in accordance with regulatory requirements.<\/p>\n
Monitor and analyze post-market data and trends to identify potential product issues and escalate to appropriate teams.<\/p>\n
Maintain up-to-date knowledge of relevant regulations and guidelines related to post-market surveillance and report any changes or updates to the team.<\/p>\n
Develop and maintain procedures and processes for post-market surveillance activities.<\/p>\n
Collaborate with cross-functional teams to ensure timely and accurate completion of post-market surveillance tasks.<\/p>\n
Participate in internal and external audits to ensure compliance with regulatory requirements.<\/p>\n
Prepare and submit post-market surveillance reports to regulatory agencies as required.<\/p>\n
Communicate with internal and external stakeholders regarding post-market surveillance activities and findings.<\/p>\n
Review and assess complaints and adverse events related to products and escalate as necessary.<\/p>\n
Provide support and guidance to other departments regarding post-market surveillance requirements and activities.<\/p>\n
Maintain accurate and organized documentation of all post-market surveillance activities.<\/p>\n
Proactively identify areas for process improvement and implement solutions to enhance efficiency and effectiveness of post-market surveillance activities.<\/p>\n
Participate in product development and design control activities to ensure post-market surveillance requirements are considered.<\/p>\n
Stay current on industry trends and best practices related to post-market surveillance and incorporate into processes and procedures.<\/p>\n
Uphold company values and ensure compliance with all company and industry regulations and standards.<\/p>\n
Where is this job?<\/p>\n
This job is located at Shanghai, China<\/p>\n
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Job Qualifications<\/p>\n
Bachelor’s Degree In A Scientific Field Such As Biology, Chemistry, Or Pharmacy.<\/p>\n
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Minimum Of 3 Years Of Experience In Regulatory Affairs Compliance, With A Focus On Medical Devices.<\/p>\n
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In-Depth Knowledge Of Fda Regulations And Guidelines, Including 21 Cfr Part 820 And Iso 13485.<\/p>\n
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Experience With Medical Device Submissions, Including 510(K) And Pma.<\/p>\n
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Strong Attention To Detail And Ability To Interpret Complex Regulatory Requirements.<\/p>\n
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Required Skills<\/p>\n
Quality Assurance<\/p>\n
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Quality<\/p>\n
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Auditing<\/p>\n
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Change Control<\/p>\n
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Risk Assessment<\/p>\n
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Regulatory Compliance<\/p>\n
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FDA Regulations<\/p>\n
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Documentation Management<\/p>\n
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SOP Development<\/p>\n
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Product Registration<\/p>\n
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Labeling Requirements<\/p>\n
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Global Submissions<\/p>\n
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Soft Skills<\/p>\n
Communication<\/p>\n
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Conflict Resolution<\/p>\n
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Leadership<\/p>\n
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Time Management<\/p>\n
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Interpersonal Skills<\/p>\n
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Creativity<\/p>\n
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Flexibility<\/p>\n
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Teamwork<\/p>\n
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Adaptability<\/p>\n
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Problem-Solving<\/p>\n","protected":false},"excerpt":{"rendered":"
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 … Read more<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-28794","post","type-post","status-publish","format-standard","hentry","category-education"],"_links":{"self":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/comments?post=28794"}],"version-history":[{"count":2,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28794\/revisions"}],"predecessor-version":[{"id":28796,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/posts\/28794\/revisions\/28796"}],"wp:attachment":[{"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/media?parent=28794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/categories?post=28794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/puranigaadi.com\/jobs\/wp-json\/wp\/v2\/tags?post=28794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}