Current jobs related to Regulatory Affairs Expert - Westlake Village, California - Caldera Medical

  • Regulatory Affairs Specialist

    1 week ago

    Westlake Village, California, United States Caldera Medical Full time

    Job Title: Regulatory SpecialistCaldera Medical is seeking a highly skilled Regulatory Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.Key Responsibilities:Develop and implement...

  • Quality Assurance Director

    1 week ago

    Westlake Village, California, United States accordance search group Full time

    Job OverviewAccordance Search Group is seeking a highly skilled Quality Assurance Manager to lead and manage our Quality Affairs team. This is a critical role that requires a strong leader with a proven track record of driving quality improvements and ensuring compliance with regulatory standards.Key ResponsibilitiesDevelop and implement quality processes...

  • Associate General Counsel, Regulatory Expert

    1 week ago

    Elk Grove Village, Illinois, United States Financial Industry Regulatory Authority Full time

    Job SummaryWe are seeking a highly experienced and skilled Regulatory Counsel to join our team at the Financial Industry Regulatory Authority (FINRA). As a key member of our Office of General Counsel, you will play a critical role in directing and managing the complete life cycle of the adoption of new regulatory requirements.Key Responsibilities:Advise the...

  • Compliance Specialist

    4 days ago

    Queens Village, New York, United States SHINDA MANAGEMENT CORPORATION Full time

    Job Summary:Shinda Management Corporation is seeking a highly skilled Compliance Specialist to join our team. As a Compliance Specialist, you will be responsible for maintaining our portfolio in accordance with regulatory program and agency requirements, applicable Fair Housing Laws, and company policy and procedures.Key Responsibilities:Ensure compliance...

  • DB2 Performance Expert

    3 weeks ago

    Westlake, Ohio, United States Fidelity TalentSource LLC Full time

    Job Title: DB2 Performance ExpertWe are seeking a highly skilled DB2 Performance Expert to join our team. As a DB2 Performance Expert, you will be responsible for ensuring the efficient and high-performance operation of DB2 systems.Key Responsibilities:Monitor and analyze DB2 system performance to identify areas for improvementDevelop and implement...

  • Principal/Utility Regulation and Finance Expert

    4 weeks ago

    Elk Grove Village, Illinois, United States CRA International Full time

    About Charles River AssociatesCRA International is a leading consulting firm that offers a unique opportunity for professionals to work with a diverse group of consultants, industry experts, and academics. With over 50 years of experience, CRA has established itself as a premier firm in the industry, providing economic, financial, and business analysis to...

  • Oil and Gas Regulatory Compliance Specialist

    2 days ago

    Greenwood Village, Colorado, United States Core Ventures LLC Full time

    Company Overview: Rad Pros is a leading provider of specialized field services, supporting essential industries across the mountains and plains states and beyond. Our team of experts is well-known for managing radioactive and hazardous materials, and we are committed to protecting the environment and workers through uncompromised service and integrity.The...

  • Medical Science Liaison

    1 week ago

    Elk Grove Village, Illinois, United States Rhythm Pharmaceuticals Full time

    Job Title: Senior Medical Science LiaisonJob SummaryRhythm Pharmaceuticals is seeking a highly skilled Senior Medical Science Liaison to join our Field Medical team. As a trusted scientific partner, you will serve as a credible source of clinical and scientific data to key stakeholders within the North America Region.Key ResponsibilitiesEstablish and...

  • Data Engineer

    1 week ago

    Westlake, Ohio, United States Fidelity TalentSource LLC Full time

    About the RoleWe are seeking a highly skilled Data Engineer to join our team at Fidelity TalentSource LLC. As a Data Engineer, you will play a critical role in designing, building, and maintaining our cloud-based data platforms.Key ResponsibilitiesDesign and implement data pipelines and ETL processes using AWS servicesDevelop and maintain scalable and...

  • EHS Manager

    4 days ago

    Elk Grove Village, Illinois, United States gpac Full time

    Job Title: EHS Manager - Spanish/English Language ExpertJob Summary: We are seeking a highly skilled EHS Manager to lead our environmental, health, and safety compliance and management system functions and activities. The ideal candidate will have a strong background in EHS management, bilingual skills in Spanish and English, and experience in a...

  • Medical Science Liaison Specialist

    3 weeks ago

    Elk Grove Village, Illinois, United States Rhythm Pharmaceuticals Full time

    Job OpportunityRhythm Pharmaceuticals is seeking a highly skilled Medical Science Liaison to join our Field Medical team. As a trusted scientific partner, you will establish and maintain relationships with key stakeholders in the medical and scientific community, providing credible clinical and scientific data to support our research...

  • Corporate Counsel

    2 weeks ago

    Westlake, Ohio, United States Nordson Full time

    Job SummaryNordson Corporation is seeking a highly skilled Corporate Counsel to provide general legal support on a wide range of topics, including contractual, commercial, and supply chain matters. The ideal candidate will have a strong background in contract drafting and negotiation, as well as experience in Uniform Commercial Code (UCC) and global...

  • Nursing Director

    49 minutes ago

    Westlake Village, United States Sunrise Senior Living Full time

    Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 7th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME Sunrise of Westlake Village Job ID 2024-219295 JOB OVERVIEW The Resident Care Director (RCD) serves as...

  • Senior Plan Consultant

    1 month ago

    Westlake, Ohio, United States Fidelity Investments Full time

    Job DescriptionThe Senior Plan Consultant plays a critical role in providing document and ERISA compliance support to clients and investment professionals. This position requires a solid understanding of ERISA and qualified plan rules under the Internal Revenue Code.Key ResponsibilitiesAnalyze prior plan documents to ensure compatibility with Fidelity's...

  • Corporate Counsel

    3 weeks ago

    Westlake, Ohio, United States Nordson Full time

    Job SummaryNordson Corporation is seeking a highly skilled Corporate Counsel to join our team. As a key member of our Legal Department, you will provide general legal support on a wide range of topics, including contractual, commercial, and supply chain matters, as well as M&A and due diligence support, regulatory and compliance, litigation support,...

  • Senior Operations Manager

    2 weeks ago

    Westlake, Ohio, United States Equity Trust Full time

    Job SummaryThe Senior Manager of Operations provides strategic leadership and direction to operational activities at Equity Trust Company, driving growth and profitability. This role requires a strong understanding of the company's core values and the ability to lead a team to achieve exceptional client experiences.Key ResponsibilitiesEnsure client service...

  • Director, Internal Audit

    1 week ago

    Westlake, Texas, United States Charles Schwab Full time

    Job SummaryThe Charles Schwab Corporation is seeking a highly skilled Director, Internal Audit - Risk Analytics/Modeling to join our team. As a key member of our Internal Audit Department, you will be responsible for leading the execution of internal audits for the enterprise, with a focus on risk analytics and modeling. This role requires a strong...

  • Senior Operations Manager

    1 week ago

    Westlake, Ohio, United States Equity Trust Company Full time

    Job SummaryThe Senior Manager of Operations provides strategic leadership and direction to maximize growth and profitability. This role requires a strong understanding of the company's core values and the ability to lead a team to achieve exceptional client service levels.Key Responsibilities:Ensure client service levels are met or exceeded while maintaining...

  • Corporate Counsel

    1 week ago

    Westlake, Ohio, United States Nordson Full time

    Job SummaryNordson Corporation is seeking a highly skilled Corporate Counsel to join our team in Industrial Precision Solutions. As a key member of our legal department, you will provide general legal support on a wide range of topics, including contractual, commercial, and supply chain matters. Your expertise will be essential in navigating complex legal...

  • Vice President of Contracts

    4 weeks ago

    Westlake, Ohio, United States Fidelity Investments Full time

    About the RoleWe are seeking a highly skilled and experienced Vice President of Contracts to join our team at Fidelity Investments. As a key member of our Contracts Management team, you will be responsible for providing strategic leadership and guidance on all aspects of contract negotiation and management.Key ResponsibilitiesLead the development and...

  • Senior Plan Consultant

    4 months ago

    Westlake, United States Fidelity Investments Full time

    Job Description : Role The Senior Plan Consultant provides document and ERISA compliance support to clients, and investment professionals and business line personnel who sell, market and service the 401(k)/403(b) retirement business. The Plan Consultant serves as a subject matter expert advisor on document, compliance and servicing issues, and...

  • Machine Learning

    2 weeks ago

    Village, United States Jobot Full time

    Dice is the leading career destination​ for tech experts at every stage of their careers.  Our client, Jobot, is seeking the following.  Apply via Dice today!Machine Learning Hiring in OKC at Top I.T Consulting ShopThis Jobot Job is hosted by: Ryan KilroyAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary:...

Regulatory Affairs Expert

2 months ago

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

Position: Regulatory Specialist

Location: Westlake Village, CA; Onsite - No remote option.

Company Mission: Enhancing Women's Quality of Life

As a Regulatory Specialist, you will be responsible for crafting and executing regulatory strategies for medical devices to secure timely approvals from global regulatory authorities. Your role will involve authoring regulatory submissions and providing essential insights to cross-functional teams, ensuring that all submissions are meticulously prepared and adhere to international regulations. This position requires on-site presence and may involve additional hours or travel to meet project deadlines.

  • Collaborate with a multidisciplinary team to deliver regulatory support for both new product launches and existing products. Engage with quality assurance, engineering, and technical experts to address potential regulatory challenges and inquiries from regulatory bodies.
  • Offer regulatory guidance to cross-functional partners, formulating global regulatory strategies for all devices and preparing submissions for both domestic and international markets.
  • Compile Technical Files/Design Dossiers, Change Notifications, and submissions (e.g., Documentary Audits under MDD/MDR) for regulatory agencies and distributors.
  • Review and authorize change requests.
  • Assist in defining regulatory strategies and oversee submission activities for complex product development and maintenance of existing approved products.
  • Interpret new or existing regulatory requirements in relation to the product portfolio and regulatory quality system procedures.
  • Support or prepare regulatory submissions for new products and modifications to ensure timely market approvals. Review significant submissions with management and negotiate issues with agency representatives.
  • Evaluate protocols and reports to support regulatory submissions.
  • Maintain expertise in global quality and regulatory standards.
  • Exhibit strong project management, writing, coordination, and execution skills in regulatory matters, focusing on technical and scientific activities.
  • Provide regulatory insights for product lifecycle planning.
  • Offer ongoing support and feedback to product development teams regarding regulatory concerns.
  • Assist with clinical studies by preparing and/or submitting regulatory documents, facilitating site interactions, supporting site requests, and maintaining study documentation.
  • Additional responsibilities may be assigned as needed.

Essential 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, ideally within the Medical Device sector.
  • Familiarity with Class II medical devices, including implants.
  • Experience with 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.

Preferred Qualifications:

  • Experience with clinical trials.
  • Ability to effectively collaborate within project teams.
  • Capability to manage multiple priorities and oversee programs with minimal supervision.
  • Strong analytical and problem-solving abilities.
  • Experience with medical device software requirements and regulations.
  • Ability to identify risks and escalate issues as necessary.
  • Prior involvement with product development teams.
  • Solid understanding of the product development process and design control.
  • Proficient in writing clear and comprehensible technical documents, including regulatory submissions and scientific presentations.
  • Experience in gathering data from various sources, analyzing it, and providing informed recommendations.
  • Demonstrated knowledge in regulatory pathways, risk-benefit analysis, and quality assurance.
  • Highly organized, efficient, process-oriented, with a keen attention to detail.
  • Excellent interpersonal and communication skills.
  • Support products throughout their lifecycle from initial concept to end-of-life.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, and Adobe).
  • Regulatory Affairs Certification (RAC) is a plus.

About Caldera Medical:

Caldera Medical is a dynamic medical device company focused on 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. Our products are utilized by healthcare professionals worldwide.

Compensation and Benefits:

  • Base salary of $95,000
  • Medical and Dental Benefits – 75% coverage for employees and their families
  • Vision Insurance
  • Life Insurance and AD&D
  • Unlimited Vacation Policy
  • 6 weeks of paid Maternity Leave
  • 401(k) plan with 4% matching contributions

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