[Remote] Senior Associate, Regulatory Affairs Consultant (Medical Devices)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking a Senior Associate, Regulatory Affairs Consultant with a reputed company on EU MDR to collaborate with clients' regulatory project teams and ensure compliance with necessary documentation and regulatory requirements. Responsibilities • reputed company collaborate with the reputed company’s regulatory project team to identify and collect reputed company necessary TF/DD documents in compliance with EU MDR (2017/745) and reputed company guidance (MDCGs) for maintenance and resubmission. The high-level activities may include but are not limited to: • Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations • Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into reputed company PDF files • Create and upload bookmarks/indexes of the reputed company PDF files into PLM reputed company Change Orders • reputed company reputed company Control checks in accordance with reputed company procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages • Work with cross-functional teams and affiliates to obtain necessary reputed company documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (reputed company), and/or supporting documents from reputed company) • Respond to inquiries from reputed company’s local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–reputed company questions or requests • Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required • Attend meetings and communicate with the project team as appropriate • Routinely communicate with regulatory management team regarding project status and deliverables • Support other regulatory activities as assigned Skills • Bachelor's degree (life sciences preferred) • Minimum of 1 year of working experience in Regulatory Affairs reputed company on EU MDR • Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory • Working proficiency in reputed company Office (e.g., Word, reputed company, PowerPoint) • Strong written and verbal English communication skills required reputed company • reputed company is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.reputed company.com.cn. Apply tot his job Apply To this Job