Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. The ideal candidate should be strong in analytical skills , knowledge about requirements for APAC specifically, ability to manage projects, and time management.
Job Title: Regulatory Specialist
Location: Alameda , CA Pay Range: $50-$55/hr on W2 Education: Bachelor's degree
Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries.
Job Description (Expectation) Responsible for regulatory activities, including product registrations, regulatory impact assessments, etc. Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning. Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve. Plan and execute the given tasks proactively in a timely manner. Report the status to a manager weekly. Keep the training records up to date to do the tasks. Able to start projects immediately after internal system training. Other Knowledge of International Standards, such as ISO 13485 and IEC 60601. Knowledge of interactions between RA and other departments to pre/post-market RA activities. Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc. Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency. Able to manage time and projects. Able to complete the tasks with minimum supervision. Strictly work 40 hours per week.
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About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands- Manpower, Experis, Talent Solutions, and Jefferson Wells- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity-as the best place to work for Women, Inclusion, Equality and disability-and in 2022, ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year, all confirming our position as the brand of choice for in-demand talent.
