Regulatory Specialist
17 hours ago
Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women As a regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our Westlake Village location and may require additional hours and/or travel as necessary to complete time-sensitive projects. • Work with a cross-functional team to provide regulatory support for new product introduction and existing products. Work with quality, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies. • Provide regulatory input and guidance to cross-functional partners, developing global regulatory strategies for all devices and preparing and submitting regulatory submissions in the both the US and OUS geographies. • Prepare Technical Files /Design Dossier, Change Notifications, Submissions (e.g. Documentary Audits under MDD/ MDR) for both regulatory agencies and distributors. • Creates, reviews and approves change requests. • Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products. • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures. • Support or prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. • Reviews protocols and reports to support regulatory submissions. • Maintain proficiency in global quality and regulatory requirements. • Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities. • Provide regulatory input to product lifecycle planning. • Provide feedback and on-going support to product development teams for regulatory issues and questions. • Provide support for clinical studies, such as preparing and/or submitting regulatory documents, interaction between sites, support site requests, technical documentation, maintenance of all study files. • Responsibilities may include the following and other duties may be assigned. • Minimum Requirements: • B.S. degree in a biomedical, biotechnology, regulatory sciences, certifications with RAPS, ASQ, CQE preferred. • 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry. • Experience with Class II medical devices, including implants. • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745. • Working knowledge of ISO 13485 and ISO 14971 standards 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 • $95,000 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.
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