Regulatory Affairs Specialist I
Penumbra
Summary
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.
Job description
What You'll Work On
- 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.
What You Contribute
- 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
Working Conditions
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.
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Paid Parental Leave
- Paid Company Holidays
- Paid Vacation
- Paid Sick Time
- Equity Program
Company overview
Penumbra, Inc. is a global medical device company headquartered in Alameda, California, specializing in innovative interventional therapies for challenging vascular conditions. Founded in 2004 by Arani Bose and Adam Elsesser, the company has established itself as the world's leading thrombectomy company, focusing on developing advanced technologies for ischemic stroke, pulmonary embolism, and acute limb ischemia treatment. Penumbra's flagship technology is Computer Assisted Vacuum Thrombectomy (CAVT), a revolutionary platform that combines sophisticated algorithms with maximum aspiration power to enable rapid, safe, and effective blood clot removal. The company's product portfolio includes the Lightning Flash, Lightning Bolt, and Penumbra ENGINE systems, which are designed to address thrombus removal from head-to-toe with unprecedented speed and precision. Operating in over 100 countries, Penumbra supports healthcare providers through its direct sales organization and distributor networks, consistently delivering clinical innovations that improve patient outcomes and reduce healthcare costs. As a publicly traded company on the NYSE (PEN) with approximately 4,200 employees, Penumbra continues to pioneer advancements in endovascular care while maintaining a strong commitment to research and development in the medical device sector.