Regulatory Affairs Specialist II
Job Summary
Job Description
As a Regulatory Affairs Specialist II, you will collaborate with the Regulatory Affairs team to ensure Penumbra products are approved for use worldwide, contributing to bringing life-saving technologies to patients. You will prepare and maintain documents for regulatory submissions, including 510(k), CE-Mark, UKCA Mark, and more. Responsibilities also include tracking device projects, ensuring regulatory documentation is maintained, researching regulatory intelligence, communicating with stakeholders, supporting labeling reviews, and assisting with audits. This role offers the chance to contribute to a company that is revolutionizing the treatment of devastating diseases.
Must have:
- Bachelor's degree in science or related field.
- Proven ability to use technical standards and concepts.
- Strong communication skills, both written and oral.
- Proficiency in MS Word, Excel, and PowerPoint.
- Excellent organizational skills and ability to prioritize.
Good to have:
- Regulatory Medical Device experience preferred.
Perks:
- Collaborative teamwork environment.
- Generous benefits package (medical, dental, vision, etc.).
- 401(k) with employer match.
- Paid parental leave.
- Paid company holidays and vacation.
5 skills required
Job Details
In this role, you will work with the Regulatory Affairs team which ensures Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will work under direct supervision and be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions of Penumbra Medical Devices.
What You’ll Work On
• Under direct supervision, assist in preparing moderately complex submissions to gain approvals such as: 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, IDE, International Clinical Trial Submission, Shonin, and Certificates to Foreign Government.
• Track multiple device projects concurrently [e.g., Design Control, post market activities, Device submission projects]
• Ensure that regulatory documentation is maintained per internal procedures.
• Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed.
• Communicate and exchange accurate information with all stakeholders (i.e., project teams, health authorities, RA personnel, and management)
• Support labeling reviews (e.g., Instructions for Use and product labels)
• Understand the Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements.
• Assist in various regulatory support activities (e.g. internal/external audits, Field Corrective Actions, FOIAs).
• Perform other Regulatory department -related duties as assigned.
What You Contribute
• Bachelor's degree in science discipline or related field with 2+ years of experience, or equivalent combination of education and/or demonstrated experience
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, theories, concepts, and techniques
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficient in Word, Excel, PowerPoint, and other computer tools
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Working Conditions
General office environment. Business travel from 0% -30%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
Annual Base Salary Range: $86,000 - $116,000 / year
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.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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