Regulatory Affairs Specialist II

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over 1 year old

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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.

What you'll work on

  • Under direct supervision, assist in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as:  IDE, non US Clinical Trial Submission, 510(k), PMA, PMA Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical Dossier, other Dossiers, and Certificates to Foreign Government
  • Track multiple projects concurrently
  • Ensure that existing approvals and documentation are maintained
  • Communicate with in-country RA personnel to facilitate global clearances/approvals Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties
  • Communicate with regulatory agencies under direct supervision
  • Assist with labeling creation, translation and review (e.g., Instructions for Use, product labels, promotional materials)
  • Assist in performing moderately complex research to support strategic planning
  • Analyze existing systems and procedures, recommend solutions/improvements, and write or revise Work Instructions and SOPs as needed to support departmental functions and the Quality System
  • Understand the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, Canadian regulations, export requirements, and regulatory requirements of pertinent regions
  • Assist in activities (e.g. execution, documentation) related to Field Corrective Actions.

    • What you bring

  • Bachelor’s degree in a science discipline and minimum 2+ years’ experience in Regulatory Affairs within a medical device company; or an equivalent combination of education and experience.
  • Minimum 1+ years’ experience preparing US 510ks and EU MDD and/or MDR submissions.
  • Working knowledge of EU MDR, Health Canada, and other submissions required.
  • Experience in providing Regulatory support on cross-functional teams for new product development and post market changes.
  • Demonstration of a keen attention to detail; ability to work independently and as part of a team.
  • Outstanding written, oral, and interpersonal communication skills.
  • The ability to perform in a fast-paced environment with a proven ability to be flexible and adaptable.
  • Proficient in Microsoft Word, Excel, SharePoint, and Adobe Acrobat preferred.
  • Basic knowledge in SAP preferred. 


    • 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. 

    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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
     
    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.
     
    PENUMBRA, INC.
    Affirmative Action and Equal Employment Opportunity Policy Statement
    As of October 14, 2022
    Penumbra, Inc. has been and will continue to be an equal opportunity employer. Employee diversity has been and will continue to be pivotal to our Company's success. Penumbra recognizes that diversity and inclusion in the workplace enhance employee engagement and stimulate innovation. To assure full implementation of this equal employment policy, we will take steps to assure that:
    a)Persons are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

    b)All other personnel actions, such as compensation, benefits, transfers, layoffs and recall from layoffs, access to training and education are administered without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

    c)Employees and applicants shall not be subjected to harassment, intimidation, threats, coercion or discrimination because they have: (1) filed a complaint; (2) assisted or participated in an investigation, compliance review, hearing or any other activity related to the administration of any federal, state or local law requiring equal employment opportunity; (3) opposed any act or practice made unlawful by any federal, state or local law requiring equal opportunity or (4) exercised any other right protected by federal, state or local law requiring equal opportunity.

    I have appointed Sharon Hughes to take on the responsibilities of EEO Coordinator. The EEO Coordinator and those designated will be responsible for the day-to-day implementation and monitoring of the Company's Affirmative Action Plan. As part of that responsibility, the EEO Coordinator will periodically analyze the Company's personnel actions and their effects to ensure compliance with our equal employment policy and administer the audit and reporting system.

    If you, as one of our employees or as an applicant for employment, have any questions about this policy or would like to view portions of the Affirmative Action Plan, please contact Ines Kramer during regular business hours. This is also a reminder that employees may update their disability status at any time by completing the voluntary self- identification of disability form on UKG Pro (found in the Private Info tab).

    I have reviewed and fully endorse our Affirmative Action and Equal Employment Opportunity program. Thank you for your continued assistance and support of our shared objective of equal employment opportunity for all.

    Adam Elsesser
    Chief Executive Officer

    If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.