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

Senior Regulatory Affairs Manager (Onsite)

CorDx

Who is CorDx?   

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Type: Full time
Job Title: Senior Regulatory Affairs Manager
Location: Onsite - Atlanta, or San Diego

Position Summary:

The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.

Key Responsibilities:

  • Prepare, review, and submit regulatory documents to FDA.
  • Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
  • Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
  • Provide regulatory guidance to R&D team during product development life cycle. 
  • Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
  • Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
  • Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
  • Represent the company in meetings with regulatory agencies and external partners as needed.
  • Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.

Requirements

  • Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Minimum of 7-10 years of experience in regulatory affairs within the medical device industry.
  • Proven track record of leading and successfully obtaining 510(k) and clearances/approvals.
  • Experience in interacting with FDA and other regulatory agencies.

Skills & Competencies:

  • In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
  • Strong leadership and project management skills, with the ability to manage multiple projects and priorities.
  • Excellent communication, negotiation, and problem-solving skills.
  • Ability to work collaboratively in a cross-functional team environment.
  • Detail-oriented with strong organizational skills.

Benefits

  • Highly competitive compensation package.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with generous company contributions.
  • Flexible paid time off (PTO) policy.
  • Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Vacancy posted 15 hours ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Manager (Onsite) in San Diego, CA vacancy
  •  ...Position : Senior Principal Software Engineer – Onsite (Proficiency in C++/C, embedded, real-time, multi-threaded software design and development & QNX...  ...of development in a process-oriented/regulated environment and adherence to a quality management system.... 
    Senior
    Contract work
    Day shift

    MILLENNIUMSOFT

    San Diego, CA
    2 days ago
  • $180k - $190k

     ...requires a civil engineering degree, a professional license, and at least 10 years of experience in construction management and field engineering. Compensation ranges from $180,000 to $190,000 annually, emphasizing onsite collaboration with clients. #J-18808-Ljbffr Accenture
    Senior

    Accenture

    San Diego, CA
    3 days ago
  •  ...chain, and government affairs teams to translate complex...  ...requires full-time onsite work in San Diego, CA...  ...engineering and product management functions to properly...  ..., compliance, and/or regulatory experience, with significant...  ...and motivates peers, senior leaders, and employees... 
    Senior
    Full time
    Work experience placement
    Relocation package

    Qualcomm

    San Diego, CA
    3 days ago
  •  ...Senior Vice President, Legal and Chief Compliance Officer (CCO) About the Company Nationally recognized healthcare services...  ...maturing an enterprise compliance program, translating legal and regulatory requirements into operational guidance, and leading the legal... 
    Senior

    Confidential

    San Diego, CA
    1 day ago
  • Nucleus Biologics is looking for a Senior Quality Engineer in San Diego, California. This role entails ensuring compliance...  ...strong attention to detail, and be willing to work 100% onsite. The role requires managing multiple tasks effectively, collaborating across teams, and... 
    Senior

    Nucleus Biologics

    San Diego, CA
    3 days ago
  • $173k - $249k

    Quantum-Design-Inc. seeks a Senior Global Controller to manage global close processes and ensure GAAP compliance across multiple entities. This role...  ...progressive accounting experience, alongside ERP proficiency. Full onsite position required at Quantum Design headquarters in San... 
    Senior

    Quantum-Design-Inc.

    San Diego, CA
    1 day ago
  •  ...lifting up to 50lbs. This role requires the ability to multitask in a fast-paced environment and operate a forklift. The job is 100% onsite at 5751 Pacific Center Blvd, with scheduled shifts from 6:00 am to 2:30 pm PST or 6:30 am to 3:00 pm PST. #J-18808-Ljbffr ALTEN
    Senior
    Shift work

    ALTEN

    San Diego, CA
    2 days ago
  • $180k - $220k

    A leading diagnostic equipment manufacturer in San Diego is seeking a Senior Electrical Engineer/Team Lead to provide project-level technical leadership. In this fully onsite role, you will drive innovative electronic designs and collaborate with cross-functional teams... 
    Senior

    SeeScan LLC

    San Diego, CA
    3 days ago
  • Kratos Defense and Security Solutions is seeking a senior level Accountant to join their team in San Diego. This onsite position may transition to hybrid after training. The Accountant will manage various accounting systems and ensure compliance with regulations. The ideal... 
    Senior

    Kratos Defense and Security Solutions

    San Diego, CA
    4 days ago
  • $90k - $110k

     ...seeking an experienced Litigation Secretary. This full-time, fully onsite position requires supporting attorneys in a fast-paced environment. Key responsibilities include drafting legal documents, managing calendars, and communicating with clients and courts. Ideal... 
    Senior
    Full time

    LHH

    San Diego, CA
    2 days ago
  •  ...IT is seeking an experienced Field Technician II to provide dedicated IT support to a key customer. This unique role involves both onsite and remote support for desktop, server, and networking issues. The ideal candidate will have over 5 years of experience and strong... 
    Senior
    Remote job

    HARBOR IT

    San Diego, CA
    4 days ago
  • $150k - $190k

     ...construction plans. Candidates must have at least 8 years of experience in roadway inspection and be knowledgeable in structural mechanics. The compensation ranges from $150,000 to $190,000 per year, and the position requires onsite work with clients. #J-18808-Ljbffr Accenture
    Senior
    For contractors

    Accenture

    San Diego, CA
    3 days ago
  • Ricoh USA, Inc. is seeking a Legal Senior Onsite Service Specialist to operate in a legal services environment. The successful candidate...  ...matter workflows, providing excellent customer service, and managing service requests. Candidates must possess a high school diploma... 
    Senior

    Ricoh USA, Inc.

    San Diego, CA
    15 hours ago
  • $100k - $140k

    Zachary Piper Solutions is seeking a Senior Linux System Administrator for an onsite position in San Diego, CA. The role involves installing, configuring, and supporting LAN and WAN systems, ensuring network availability, and administering network security measures. Candidates... 
    Senior

    Zachary Piper Solutions

    San Diego, CA
    15 hours ago
  • $125k - $160k

    A technology firm in San Diego is seeking an iOS Developer to enhance their utility locating applications. This fully onsite role involves developing and maintaining iOS applications, optimizing app performance, and collaborating in code reviews. Ideal candidates will... 
    Senior

    SeeScan LLC

    San Diego, CA
    3 days ago
  • $50 - $65 per hour

    Yoh, A Day & Zimmermann Company is seeking a Senior Accountant for an onsite opportunity in San Diego, CA. This role involves supporting month-end close processes, reviewing financial data, and preparing reports using advanced Excel tools. The ideal candidate will have... 
    Senior
    Contract work

    Yoh, A Day & Zimmermann Company

    San Diego, CA
    1 day ago
  • $40 - $50 per hour

     ...leading nutrition services provider is seeking a Hybrid Remote/Onsite Dietitian in San Diego, California. This role involves providing Medical Nutrition Therapy and education to enhance outcomes in senior living. Candidates should be a registered dietitian with relevant... 
    Senior
    Remote job
    Hourly pay

    Compass Group USA

    San Diego, CA
    4 days ago
  • $120k - $165k

     ...BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today...  ...functional teams to develop and execute regulatory strategies that support business...  ...Minimum of 8 years of regulatory affairs experience in the medical device industry... 
    Senior
    Work at office
    Local area
    Flexible hours

    Pacira Pharmaceuticals

    San Diego, CA
    2 days ago
  •  ...Investigation Lab/Post Market - Onsite Location : San Diego, CA...  ...Level of Experience : Senior Level Employment Type : Contract...  ...complaint file documentation and regulatory reporting decision activities...  ...questions of team leaders / management as needed. Collaborate... 
    Senior
    Contract work
    Day shift

    MILLENNIUMSOFT

    San Diego, CA
    2 days ago
  • $240k - $265k

     ...a clinical‑stage biopharmaceutical company focusing on oral small molecule therapies. The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/CTA preparations, meetings, and maintenance to support new and ongoing development... 
    Senior
    Work at office
    Remote work
    Flexible hours

    Internetwork Expert

    San Diego, CA
    15 hours ago
  •  ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type...  ...activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that the... 
    Senior

    Confidential

    San Diego, CA
    12 days ago
  • Contineum Therapeutics is seeking a Senior Director of Regulatory Affairs in San Diego, CA. This role leads regulatory activities for IND/CTA preparations and requires significant experience in the pharmaceutical/biotech industry. Candidates should have a Bachelor's degree... 
    Senior
    Remote job

    Internetwork Expert

    San Diego, CA
    15 hours ago
  • $204.2k - $306.2k

     ...Compliance General Summary: The Senior Director of Export and Import...  ...oversee compliance programs, manage risk, ensure appropriate...  ...matters. Monitor regulatory changes and assess their impact...  ...Sanctions Compliance, International Affairs, or related work experience,... 
    Senior
    Work experience placement
    Work from home

    Jobleads-US

    San Diego, CA
    1 day ago
  • $40.05 - $50.06 per hour

     ...administrative support to a Department Chief and Management Support staff for a large public utility...  ...8:00am-5:00pm Pay: $40.05-$50.06 DOE Onsite role Responsibilities The Executive...  ...reports for internal stakeholders and regulatory agencies. Drafting, typing, updating,... 
    Senior
    Hourly pay
    Temporary work
    Monday to Friday

    Ultimate Staffing Services

    Spring Valley, CA
    4 days ago
  •  ...A leading biotechnology company is seeking a Senior Manager for Tax, responsible for various tax issues and oversight of tax returns. This remote position demands 7-9 years of experience in US corporate income tax and knowledge of ASC 740. Candidates with Big Four experience... 
    Senior
    Remote work

    BioSpace, Inc.

    San Diego, CA
    8 days ago
  • A global healthcare company in San Diego is seeking a Sr. Manager, Regulatory Lead. This role involves supporting the regulatory strategy for...  .... Candidates should have a strong background in regulatory affairs, with a Bachelor’s degree and extensive experience. The company... 
    Senior

    Alfasigma S.p.A.

    San Diego, CA
    1 day ago
  • $107.16k - $226.32k

     ...culture because it is an investment in our people, our future, and what we stand for as a firm. KPMG is currently seeking a Manager / Senior Manager to join our Global Compliance Management Services practice. Responsibilities: Manage assigned global compliance... 
    Senior
    Local area
    Remote work

    KPMG

    San Diego, CA
    4 days ago
  • A leading defense technology firm in San Diego seeks a Senior Director of Quality to provide executive leadership across multiple sites, ensuring compliance with quality management systems and continuous improvement. The ideal candidate will have 15+ years of experience... 
    Senior

    Leonardo DRS

    San Diego, CA
    3 days ago
  • $110k - $165k

    Palomar Holdings, Inc. is hiring a Senior Compliance Manager to oversee regulatory compliance for its expanding insurance offerings. This position requires 7+ years of experience, a bachelor's degree (with an advanced degree preferred), and strong regulatory knowledge.... 
    Senior
    Remote job

    Palomar Holdings, Inc.

    San Diego, CA
    3 days ago
  • $125k - $130k

    Simply Biotech is seeking a Quality Manager for their San Diego office. This role oversees quality assurance and control, ensuring compliance with cGMP and regulatory requirements. Candidates should have a Bachelor’s degree in a scientific discipline and over 5 years of... 
    Senior
    Work at office

    Energy Jobline ZR

    San Diego, CA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Manager (Onsite). Be the first to apply!