Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Sr. Regulatory Affairs Specialist

Full-time

Caldera Medical Inc

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
  • Our Culture- Where Career and Passion come together!

    • A Culture of family and team… not a corporate goliath where you’re just another number.
    • All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
    • The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
    • Our goal is to treat 1 million women suffering from incontinence by 2027!

    Competitive Compensation, Comprehensive Benefits, and more!

    • Medical and Dental Benefits
    • Vision Coverage
    • 401(k) with 4% matching contributions after 90 days of employment
    • Basic Life and AD&D
    • Unlimited Vacation Policy
    • 6 Weeks Paid Maternity Leave
    • 10 paid holidays
    • Being surrounded by amazing people!

    (This role is being filled internally, and we are not engaging external agencies at this time.)

    Who is Caldera Medical?

    Caldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.

    Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women’s health, aiming to provide treatment to one million underserved women by 2027.

    Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women’s health company, we remain committed to expanding education and access to life-changing care for women everywhere.

    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.

Vacancy posted more than 2 months ago
Similar jobs that could be interesting for youBased on the Sr. Regulatory Affairs Specialist in Westlake Village, CA vacancy
  •  ...Job Description Job Description Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake Village, California Sponsorship is not available for this role Caldera Medical’s Mission - To Improve the Quality of Life for Women! Message from the Hiring... 
    Senior
    Work at office
    Local area
    Worldwide

    Caldera Medical

    Westlake Village, CA
    11 days ago
  •  ...management, and other risk mitigation activities. You'll collaborate with all lines of defense departments to support adherence to regulatory commitments and the development of enhanced monitoring and controls to mitigate compliance risk. Interpret and effectively... 
    Senior

    Western Alliance Bank

    Westlake Village, CA
    4 days ago
  • Amgen is seeking a Sr Associate Compliance to partner with US Compliance Leads to implement and oversee Amgen’s Corporate Compliance programs across therapeutic areas and functions. You will develop and deliver training, monitor adherence to laws and internal policies,... 
    Senior
    Remote job

    amgen

    Thousand Oaks, CA
    4 days ago
  • A leading asset-recovery firm in Thousand Oaks, California, is seeking a professional to train attorneys and manage legal documentation. The role involves ensuring compliance with company policies, auditing files, and updating case information. Ideal candidates will work...
    Senior

    ARSI Group

    Thousand Oaks, CA
    1 day ago
  • $85.8k - $104.8k

    Job Summary The Regulatory Affairs Specialist is responsible for planning, preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents... 
    Suggested
    Contract work
    Worldwide

    Implant Direct

    Thousand Oaks, CA
    2 days ago
  • $157.74k - $213.41k

     ...of patients while transforming your career.Process Development Sr Principal ScientistWhat you will doLet’s do this. Let’s change the...  ..., technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.Deliver... 
    Senior
    Full time
    Temporary work
    Flexible hours

    Amgen

    Thousand Oaks, CA
    1 day ago
  • $32 - $33.55 per hour

     ...Duration: 05 months contract Description: In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the... 
    Senior
    Hourly pay
    Contract work
    Local area

    US Tech Solutions

    Newbury Park, CA
    5 days ago
  •  ...transfer, and guide cross-functional teams to deliver scalable, stable drug products. The role emphasizes hands-on ADC expertise, regulatory writing, and collaboration across global teams, with travel up to 10%. The company highlights a collaborative, innovative culture... 
    Senior

    Biopharma Careers

    Thousand Oaks, CA
    3 days ago
  •  ...successful commercialization and lifecycle management. The role requires advanced degrees and substantial experience in pharma/biotech, with a strong emphasis on aseptic processing, regulatory interactions, and global transfers. #J-18808-Ljbffr Initial Therapeutics, Inc.
    Senior

    Initial Therapeutics, Inc.

    Thousand Oaks, CA
    2 days ago
  •  ...of patients while transforming your career. Process Development Sr Principal Scientist What you will do In this vital role, you...  ...and enable successful process performance qualification (PPQ), regulatory submissions, marketing authorization, and commercial launch. In... 
    Senior
    Contract work
    Flexible hours

    Amgen SA

    Thousand Oaks, CA
    5 days ago
  • Implant Direct in Thousand Oaks, CA is seeking a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional... 

    Implant Direct

    Thousand Oaks, CA
    2 days ago
  • Implant Direct, part of Envista Holdings, seeks a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices from Thousand Oaks, CA. You will coordinate 510(k) filings, CE documentation, and international dossiers, working with cross-functional... 

    Envista Holdings Corporation

    Thousand Oaks, CA
    3 days ago
  • A leading biopharmaceutical company is seeking a Senior Manager for Global Forecasting. This role involves analyzing market dynamics, collaborating with stakeholders, and providing actionable insights to drive commercial success. The ideal candidate will have significant...
    Senior
    Flexible hours

    BioSpace

    Thousand Oaks, CA
    4 days ago
  • Amgen is seeking a Process Development Senior Scientist in Thousand Oaks, CA to join their analytical team focused on pivotal phase drug development. In this role, you will define strategies, optimize methods, and support drug product development to help patients with serious...
    Senior

    Amgen

    Thousand Oaks, CA
    5 days ago
  •  ...and processing complaints, disputes, fraud claims, and compliance-related requests while ensuring adherence to client guidelines, regulatory requirements, and internal procedures. The ideal candidate is highly organized, detail-oriented, and able to manage multiple... 
    Work at office
    Monday to Friday

    First Source LLC

    Thousand Oaks, CA
    1 day ago
  •  ...Sr. Mechanical EngineerBachelor's degree in Mechanical Engineering with 10-15 years of relevant experience. Proficiency with SOLIDWORKS for CAD, SolidWorks Simulation or ANSYS for FEA, and PDM/Teamcenter for data management. Complex electro-mechanical systems background... 
    Senior

    Insight Global

    Agoura Hills, CA
    13 hours ago
  • $38.54 - $50.84 per hour

    LVN Position Work Location: Westlake Village, CA, USA Onsite Fully On-Site Work Schedule Monday-Friday, 8:00am-5:00pm Salary Range: $38.54 - 50.84 Hourly Employment Type 2 - Staff: Career Duration Indefinite Primary Duties and Responsibilities Performs...
    Senior
    Hourly pay
    Monday to Friday

    UCLA Health

    Westlake Village, CA
    2 days ago
  •  ...Sr. Accounting ManagerMannKind has a newly created opportunity for a Senior Manager, Accounting. The Sr. Manager is a key part of the Finance organization and reports to our Corporate Controller. The Sr. Manager will assist in providing thought leadership and current... 
    Senior
    Work at office
    Remote work
    Monday to Thursday

    Georgia IT Inc

    Westlake Village, CA
    1 day ago
  • $95k - $110k

    Job DescriptionImportant: This role is based at our Westlake Village, CA corporate offices on a hybrid schedule (3 days onsite per week).About the Role As a Senior Financial Analyst supporting the Guitar Center Brand, you’ll play a critical role in analyzing business results...
    Senior
    Work experience placement
    Local area
    3 days per week

    Guitar Center

    Westlake Village, CA
    1 day ago
  • Reference: 629734Posted: 2026-08-20Location: Thousand Oaks, CACompany: Planet Pharma GroupContact: ApplicationsEmail: ****@*****.*** PR Range: 19-26/hr DOEIn this vital role you will be part of the Manufacturing Technical Operations (MTO) Production...
    Senior
    Flexible hours
    Shift work
    Weekend work

    Planet Pharma

    Thousand Oaks, CA
    2 days ago
  • $66 - $75 per hour

     ...Sr Full Stack Developer (NodeJS React, SQL / NoSQL, AWS) Job Location: Westlake Village, CA (Onsite, NO REMOTE) Responsibilities: Looking for a Senior Full Stack Developer (NodeJS, React, SQL / NoSQL, AWS) to take on challenging Strategic Application Development... 
    Senior
    Hourly pay
    Remote work

    TekLead

    Westlake Village, CA
    1 day ago
  • $60k - $80k

     ...Job Title The candidate will be a point of contact for state and federal regulatory examinations and will assist regulators on all requests pertaining to an examination. In addition, the individual will be responsible for developing and implementing appropriate corrective... 
    Fixed term contract
    Work at office
    Local area
    Flexible hours

    Westlake Financial Services

    Agoura Hills, CA
    5 days ago
  • Crossroads Staffing is seeking a Junior Broker-Dealer Compliance Officer in Thousand Oaks, CA to join our growing compliance team, and work closely with trading and sales. The role covers broad-based compliance across institutional trading, equity research, investment banking...

    Crossroads Staffing

    Thousand Oaks, CA
    2 days ago
  • $114.91k - $141.95k

     ...ll do: As a Compliance Assistant Manager you’ll be a subject matter expert and provide advice, oversight and guidance related to regulatory compliance risks, control effectiveness, root cause analysis, and issue review and validation. You’ll provide leadership and direction... 
    Contract work

    Western Alliance Bancorporation

    Westlake Village, CA
    5 days ago
  • $154.5k - $247.25k

     ...Worker TypeRegularJob DescriptionWe are searching for a talented Sr. Principal. Guidance, Navigation & Control (GNC) Engineer to play a critical role in developing next-generation unmanned air vehicles and robotic systems. As a key member of our innovative team, you will... 
    Senior
    Permanent employment
    Full time
    Contract work
    Work experience placement
    Work at office

    AeroVironment

    Moorpark, CA
    2 days ago
  • $135k - $150k

    Job DescriptionPosition Summary: Sr. Manager, Omni-Channel ServicesThe Sr. Manager, Services Marketing, reporting to the VP of Omnichannel Marketing, will lead the marketing strategy and execution for Guitar Center’s core services, including Financing, Pro Coverage, Rentals... 
    Senior
    Seasonal work
    Local area

    Guitar Center

    Westlake Village, CA
    7 hours ago
  • $115.39k - $156.12k

     ...them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Scientist/Sr Scientist What You Will DoLet’s do this. Let’s change the world. We are seeking a motivated Scientist or Senior Scientist in mass spectrometry... 
    Senior
    Full time
    Flexible hours

    Amgen

    Thousand Oaks, CA
    7 hours ago
  •  ...Sr. Devops Engineer Agoura Hills, CA (onsite interview) Long term contract (6 months +) 2 days onsite each week The Senior DevOps Engineer on the Cloud Engineering team will be responsible for designing, automating, and optimizing cloud infrastructure and deployment... 
    Senior
    Long term contract
    Work experience placement
    2 days per week

    Sky Systems

    Agoura Hills, CA
    4 days ago
  • Firstsource is a specialized global business process management partner. We provide transformational solutions and services spanning the customer lifecycle across Healthcare, Banking and Financial Services, Communications, Media and Technology, and other diverse industries...
    Senior

    ARSI Group

    Thousand Oaks, CA
    1 day ago
  • $100.7k - $131k

     ...Select how often (in days) to receive an alert: Sr. Mechanical Engineer Experience Level: Professional Job Type: Regular Location: Newbury Park, CA, US, 91320 Requisition ID: 10518 Qorvo (Nasdaq: QRVO) supplies innovative semiconductor solutions that make a better world... 
    Senior
    Work at office

    Qorvo

    Thousand Oaks, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Sr. Regulatory Affairs Specialist. Be the first to apply!