Regulatory Affairs Associate Jobs

Job Title: Regulatory Affairs Associate

Location: Alameda, CA 94502

Duration: 12 months

This job role will be based in Alameda, reporting into the Europe, Middle East, Africa and Pakistan regulatory team. The successful individual will be responsible for authoring and maintaining technical files for Europe and UK for medical devices (Class IIa/IIb) and IVDs (Class A-C) in accordance with MDR & IVDR. Working with state-of-the-art products and leading technology, the individual will be responsible for management of design changes, including but not limited to conducting regulatory impact assessments, review and approval of labelling, design documentation, clinical evaluation and working with the global team to implement changes in line with the business strategy. Assessment and implementation of new regulations, such as UKCA marking.

• Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.
• Typically reports to a manager.
• Experience with global regulations and/or CE marking beneficial.
• Requires an advanced degree in science, engineering or related discipline and a minimum of 3 years experience in medical device regulatory affairs.
• A wide degree of creativity and latitude is expected.
• May lead and direct the work of others.