Job Description

Summary: Technical Documentation), CE Marking dossiers, 510(k) (if applicable), and country-specific submissions.

• Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters

Desired Qualifications:

• Experience with clinical studies.
• Ability to work effectively on project teams.
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
• Strong analytical and problem-solving skills.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.
• Prior direct involvement with product development teams.
• Good understanding of product development process and design control.
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation and scientific presentations.
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations.
• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance.
• Organized, efficient, process-oriented, high attention to detail.
• Effective interpersonal/communication skills.
• Supporting products from initial concept through end-of-life phases.
• Demonstrated MS Suite proficiency (e.g. Microsoft Word, Excel, Office, PowerPoint, and Adobe).
• Regulatory Affairs Certification (RAC).

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

Competitive Compensation, Comprehensive Benefits, and more!

• $130,000 base salary
• Medical and Dental Benefits – 75% paid for employee and family members
• Vision Insurance
• Life Insurance, AD&D
• Unlimited Vacation
• 6 weeks of paid Maternity Leave
• 401(k) with 4% matching contributions

Hear it from our very own! Learn more about Caldera on Glassdoor

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.

Job Tags

Full time, Worldwide,

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