Regulatory Affairs Expert

2 weeks ago


Westlake Village, California, United States Caldera Medical Full time
Job Overview

Position: Regulatory Specialist

Company: Caldera Medical

Mission: Enhancing Women's Quality of Life

As a Regulatory Specialist, you will be responsible for formulating and executing regulatory strategies for medical devices to secure prompt approvals from international regulatory authorities. Your role will involve drafting and managing regulatory submissions while collaborating with cross-functional teams to ensure compliance with global standards.

Key Responsibilities:
  • Collaborate with multidisciplinary teams to deliver regulatory support for both new product launches and existing product lines, addressing regulatory inquiries and challenges.
  • Provide strategic regulatory insights to internal partners, crafting global regulatory approaches for all devices and overseeing submission processes in both domestic and international markets.
  • Prepare comprehensive Technical Files, Design Dossiers, and Change Notifications for regulatory agencies and distribution partners.
  • Review and authorize change requests, ensuring alignment with regulatory requirements.
  • Assist in defining regulatory strategies and managing submission activities for complex product development and maintenance of approved products.
  • Interpret regulatory requirements relevant to the product portfolio and ensure adherence to quality system procedures.
  • Support or prepare regulatory submissions for new products and modifications, facilitating timely market access. Engage with management to review significant submissions and negotiate with regulatory personnel.
  • Evaluate protocols and reports to bolster regulatory submissions.
  • Maintain up-to-date knowledge of global quality and regulatory standards.
  • Exhibit strong project management skills, with a focus on regulatory documentation and scientific activities.
  • Contribute regulatory insights to product lifecycle management.
  • Offer ongoing support to product development teams regarding regulatory challenges.
  • Assist with clinical study support, including the preparation and submission of regulatory documents and site interactions.
  • Additional responsibilities may be assigned as needed.
Minimum Qualifications:
  • Bachelor's degree in biomedical sciences, biotechnology, regulatory affairs, or related fields; certifications from RAPS, ASQ, or CQE are preferred.
  • 3-5 years of experience in International Regulatory Affairs, particularly within the Medical Device sector.
  • Familiarity with Class II medical devices, including implants.
  • Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC), and European Medical Device Regulation 2017/745.
  • Understanding of ISO 13485 and ISO 14971 standards.
Preferred Qualifications:
  • Experience in clinical study processes.
  • Ability to effectively collaborate within project teams.
  • Proficient in managing multiple priorities with minimal supervision.
  • Strong analytical and problem-solving capabilities.
  • Experience with medical device software regulations.
  • Ability to identify and escalate potential risks.
  • Direct involvement with product development teams.
  • Comprehensive understanding of the product development lifecycle and design control.
  • Ability to produce clear and concise technical documentation.
  • Experience in data analysis and providing informed recommendations.
  • Knowledge of regulatory pathways, risk-benefit analysis, and quality assurance practices.
  • Highly organized with a keen attention to detail.
  • Effective communication and interpersonal skills.
  • Support products throughout their lifecycle.
  • Proficient in Microsoft Office Suite and Adobe.
  • Regulatory Affairs Certification (RAC) is a plus.
About Caldera Medical:

Caldera Medical is a rapidly growing medical device company committed to enhancing the quality of life for women. Recognized as one of the fastest-growing private companies in the United States, we specialize in developing and marketing innovative surgical implants for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse, serving healthcare professionals worldwide.

Compensation and Benefits:
  • Competitive base salary
  • Comprehensive medical and dental coverage
  • Vision insurance
  • Life insurance and AD&D
  • Unlimited vacation policy
  • Generous paid maternity leave
  • 401(k) plan with matching contributions

Caldera Medical is an equal opportunity employer, considering all candidates for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, military status, sexual orientation, gender identity, or any other category protected by law.



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