About this role
Position Summary
The Senior Regulatory Affairs Specialist is responsible for acting as the local product RA expert and ensuring that the necessary technical documentation is captured, compiled, and prepared for regulatory submissions. The role supports product registration activities and acts as the local point of contact for any questions raised by regulatory authorities.
This position is based in China Shanghai Campus and reports to Senior RA Manager .
Job Responsibilities
This position is responsible for, but not limited to, the following:
- Responsible for regulatory affairs activities as needed, including required registrations, submissions, renewals, change notifications, and lifecycle maintenance.
- Responsible for product type-testing and reviewing relevant test specifications and test result documents to ensure compliance with the relevant requirements.
- Coordinate Unique Device Identification (UDI) activities and partner with Regulatory Affairs, Labeling, and cross-functional teams to maintain accurate device registration data.
- Act as product RA expert and provide guidance to local team on regulatory requirements in areas such as (but not limited to) design inputs, labelling, packaging, design verification and testing.
- Lead standards gap assessment processes, including assignment, tracking, documentation, stakeholder coordination, and completion of required actions.
- Coordinate regulatory change assessments and evaluate potential impacts across products, regions, registrations, and regulatory systems.
- Work closely with Quality Systems, Quality Engineering, and other team members to implement systems to ensure compliance with regulatory requirements.
- Assist and aide in preparation for site audits by regulatory authority audits and internal audits. Accurately records and reports of information as required.
- Other duties as may be assigned by manager.
Qualifications
- Bachelor’s degree or Master’s degree, with major in Engineering, Science or adequate professional background.
- Must have 5+ years RA experience in medical device manufacturing field with focus on Class II and Class III medical devices.
- Must have direct experience with NMPA. Experience with other global regulatory authorities is a plus.
- Must have strong verbal and written English skills. Experience working with global teams is preferred.
- Experience with overseas registration preferred.
About Straumann
The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.
Headquartered in Basel, Switzerland, the Group currently employs more than 10,000 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners.
For more information, please visit: Straumann Group