Regulatory Affairs Specialist I

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions.

 

• Under direct supervision, assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical Documentation, UKCA Mark, other regional Regulatory submissions, IDE, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
• Assist in the tracking of multiple projects concurrently
• Ensure that submission/approval documentation is maintained per internal procedures
• Support in-country RA personnel to facilitate global clearance/approvals. 
• Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed.
• Support labeling reviews (e.g., Instructions for Use and product labels). 
• Train in existing systems, Work Instructions, and SOPs as needed to support departmental functions and the Quality System.
• Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
• Support Regulatory change assessment for product changes.

 

• A Bachelor’s degree in a relevant discipline or an equivalent combination of education and or demonstrated experience

• Regulatory Medical Device experience preferred  

• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques

• Excellent written, oral, and interpersonal communication skills

• Proficiency in Word, Excel, PowerPoint and other computer tools

 

General office environment. Willingness and ability to work on site as needed. May have business travel from 0% - 30%. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

 

We offer a competitive compensation package plus a benefits and equity program, when applicable.  

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.