Life in UL in LinkedIn : https://www.linkedin.com/company-beta/4721/life/
Our website : http://www.ul.com/ ; https://www.emergobyul.com/
POSITION SUMMARY: Provide Emergo clients with consulting support for their regulatory needs related to compliance with the applicable regulations and standards. Leverage extensive CFDA submission experience and familiarity with the CFDA network. Possess managerial abilities to coach local team on CFDA regulations and device submissions. Perform work independently in accordance with written Work Instructions and the signed Project Order / SOW, and within the agreed upon timeframes established with client.
MAJOR DUTIES AND RESPONSIBILITIES:
(The duties and responsibilities used to describe the scope of the position are not necessarily limited to those outlined)
- Support clients with guidance regarding medical device classification and regulatory pathways for China market entry, as well as assisting with effective regulatory strategies.
- Support global customers with the preparation and submission of regulatory premarket dossiers for CFDA, and for other global markets, such as the US and Europe.
- Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities.
- Prepare meeting requests, and facilitate those meetings (either by teleconference or face-to-face), between clients and the CFDA or other regulatory agencies.
- Interact and negotiate directly with regulatory authorities on behalf of clients.
- Assist clients with other regulatory concerns, such as labeling, risk assessment, design change evaluation, etc.
- Review documentation and advise clients in developing more effective documentation, e.g., labeling, test reports, in conjunction with relevant standards, regulations, guidance documents, and current regulatory policies.
- Assist and coach global regulatory consultants with efforts related to CFDA regulations.
- Perform other regulatory consulting services as needed by our clients, and help customize consulting solutions to clients’ specific needs, both on-site and off-site.
- Work in close partnership with the Global Operations Team (Project Management) to deliver within scope, within budget and on time.
- Provide guidance to Business Development in determining appropriate scope and budget of proposals.
- Participate in developing and maintaining our internal Emergo services and processes.
- Review Marketing materials for accuracy, including written documents and website.
- Develop and present trainings to colleagues regarding CFDA regulations and procedures.