Senior Regulatory Affairs Specialist



Company Name:

Mainstay Medical

Job Location:

2159 India Street

Suite 200

San Diego, CA 92101

Position Title:

Senior Regulatory Affairs Specialist

Position Type:

Full time

General Job Description


Mainstay Medical is seeking a driven and passionate Senior Regulatory Affairs Specialist to work on PMA Class III/active implantable devices. This individual will be managing the regulatory processes for both the U.S. FDA and International (CE mark, Australia, and others) markets at Mainstay Medical in San Diego, California. You will develop regulatory strategies, organizing regulatory information and execute regulatory submissions to both the U.S. FDA and international regions. You will also review and advise on labeling or advertising/promotional materials for compliance with the regulatory filings. We hope you will join us on this journey to ReActiv8 life.


Responsibilities:

  • Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485)

  • Ability to work independently and with all levels of managers, associates, and teams

  • Plan, generate, and coordinate worldwide regulatory submissions for product approvals, and maintenance of existing regulatory approvals, including submitting PMA and IDE annual reports, CE mark, PMA supplements and PMA 30-day notices

  • Review engineering change orders or project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports.

  • Develop and maintain technical documentation files/design dossier in accordance with the EU regulations

  • Review labeling and ad-promo materials to ensure compliance

  • Support audits and continuous improvement activities, develop and update procedures

  • Communicate with the regulatory bodies

  • Complete all other related duties assigned.

Qualifications:

  • B.S. degree in engineering, medical, biological, or related fields

  • 3+ years’ experience in medical device regulatory affairs submissions

  • RAC certification

  • Experience with AIMDD and US Class III devices regulatory submissions

  • Excellent written and verbal communication skills

  • Project management experience

  • Excellent verbal communication and interpersonal skills.

  • Demonstrated excellent organizational skills with attention to detail.

  • Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management.

  • Problem solver and capable to find solutions to challenges.

Application Information & Contact (How to Apply)


Forward your resume to: careers@mainstay-medical.com


Learn more about the company here

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