Regulatory Affairs Specialist
2 months ago
Job Description:
The Impact You’ll Make in this Role
As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary Responsibilities include but are not limited to the following:
Provide support and expertise as part of the Regulatory organization using knowledge of China regulatory requirements and paths to ensure market access and right to operate Prepare Technical Documentation for Consumer Health products for use in China Assure that all device listings, import licenses, and registrations for Consumer Health products are accurate and up to date Advise on new regulatory strategies Review product labeling and claims for compliance to applicable regulations Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects Provide local QMS, Distribution Quality assistance, audit support as required Interface with local agencies Participate and provide support within GCA Regulatory Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance Address product changes in regulatory documentation Assist with other Asia related regulatory tasks as assigned Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
Bachelor degree or higher (completed and verified prior to start) from an accredited institution with relevant technical degree.
Ten (10) years of combined experience in Regulatory Affairs and/or regulated R&D in a private, public, government or military environment. High preference for experiences in consumer medical device and/or cosmetic product registrations. Expertise in product specific regulatory and standard requirements for China registration.
Ability and experience in interfacing with regulatory agencies and testing agencies in China
Demonstrable effective cross-functional and intercultural working experiences in a global company.
Good English speaking skillsets
Demonstrated ability to support technical efforts, with proven experience collaborating effectively with cross functional team members
Ability to multi task and prioritize personal workload to meet deadlines
Strong verbal and written communication skills with ability to provide diligent, concise and fact based communication to Executive Management and cross functional peers
Proficient in Microsoft Office Tools
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