Jobs
>
Raleigh

    Sr. Regulatory Affairs Specialist - Irvine, United States - Prismatik

    Prismatik
    Prismatik Irvine, United States

    3 weeks ago

    Default job background
    Description

    Job Description

    Job Description

    Essential Functions:

    • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
    • Maintains company registrations and device listings in the US, Canada, and the EU.
    • Analyzes and reports department metrics.
    • Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
    • Informs coordinator of product recalls.
    • Performs and supports internal, external, and third-party audits.
    • Maintains knowledge on current regulations and guidelines.
    • Evaluates compliance with applicable regulations, project policies, and procedures
    • Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
    • Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
    • Composes audit plans and reports.
    • Conducts audits and inspections of GMP and non-regulated documentation.
    • Tracks internal and external corrective and preventive actions.
    • Performs other related duties and projects as business needs require at direction of management.

    Education and Experience:

    • Bachelor's degree in related field preferred.
    • Minimum five (5) years of experience in Regulatory Affairs.

    Knowledge and Abilities:

    • Proficient knowledge of general office procedures.
    • Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
    • Proficient quantitative and analytical skills.
    • Demonstrated prioritization and time management skills.
    • Demonstrated negotiation abilities.
    • Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
    • Demonstrated high standard of quality of work.
    • Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
    • Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
    • Demonstrated reliability, dependability, and flexibility in work habits.
    • Demonstrated attention to detail and accuracy.
    • Ability to analyze and collate data for presentations and reports.
    • Ability to prioritize and organize project tasks and goals effectively.
    • Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
    • Ability to interpret and collate data to present an accurate picture of market potential.
    • Ability to research new and emerging technologies and practices.
    • Ability to read technical diagrams, graphs, and instructions.

    Pay: $85K-$130K

  • Stryker Corporation

    Regulatory Affairs Specialist, Cosmetics

    3 weeks ago

    Stryker Corporation Cary, United States

    **Why RA/QA at Stryker?**: · We are currently seeking a **Regulatory Affairs Specialist** to join our **Medical Division**. This is a hybrid role based in Cary, IL. · **Who we want** · - ** Detail-oriented process improvers. **Critical thinkers who naturally see opportunities to ...

  • Merz Pharmaceuticals USA

    Regulatory Affairs Senior Specialist

    3 weeks ago

    Merz Pharmaceuticals USA Raleigh, United States

    The Regulatory Affairs Senior Specialist - Medical Devices coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as th Regulatory Affairs, Medical, ...

  • EPM Scientific

    Senior Regulatory Affairs Specialist

    1 week ago

    EPM Scientific Raleigh, United States

    Title: Senior Regulatory Affairs SpecialistSalary : $100,000 to $110,000Summary:A global medical device company is seeking a driven and experienced person to fill their Senior Regulatory Affairs Specialist role in their facility located in the greater Charlotte area. This person ...

  • EPM Scientific

    Senior Regulatory Affairs Specialist

    1 week ago

    EPM Scientific Raleigh, United States

    Title: · Senior Regulatory Affairs Specialist · Salary: · $100,000 to $110,000 · Summary: · A leading global medical device company is looking for a motivated and experienced individual to join their team as a Senior Regulatory Affairs Specialist at their facility in the grea ...

  • EPM Scientific

    Senior Regulatory Affairs Specialist

    1 week ago

    EPM Scientific Raleigh, United States

    Title: · Senior Regulatory Affairs Specialist · Salary : $100,000 to $110,000 · Summary: · A global medical device company is seeking a driven and experienced person to fill their Senior Regulatory Affairs Specialist role in their facility located in the greater Charlotte area ...

  • Merz Pharmaceuticals USA

    Regulatory Affairs Senior Specialist

    2 weeks ago

    Merz Pharmaceuticals USA Raleigh, United States

    The Regulatory Affairs Senior Specialist - Medical Devices coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as the development and implementati ...

  • Merz North America

    Regulatory Affairs Senior Specialist

    3 weeks ago

    Merz North America Raleigh, United States

    The Regulatory Affairs Senior Specialist - Medical Devices coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as the development and implementati ...

  • Stryker

    Senior Staff Regulatory Affairs Specialist

    1 week ago

    Stryker Raleigh, United States

    Work Flexibility: Remote · Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient ...

  • Teleflex

    Regulatory Affairs Specialist

    3 weeks ago

    Teleflex Morrisville, United States

    Expected Travel: Up to 10% · Requisition ID: 10017 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit ...

  • Bioventus

    Senior Regulatory Affairs Specialist

    1 week ago

    Bioventus Durham, United States

    Are you ready to work for a more active world? · At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our suc ...

  • PSI CRO

    Regulatory Affairs Specialist

    3 weeks ago

    PSI CRO Durham, United States

    Company Description · PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of thera ...

  • Grifols Shared Services North America, Inc

    Senior Regulatory Affairs Specialist II

    8 hours ago

    Grifols Shared Services North America, Inc Clayton, United States

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...

  • Grifols Shared Services North America, Inc

    Senior Regulatory Affairs Specialist II

    1 week ago

    Grifols Shared Services North America, Inc Clayton, United States

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...

  • Grifols S.a.

    Senior Regulatory Affairs Specialist II

    2 weeks ago

    Grifols S.a. Clayton, United States

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...

  • Grifols, S.A

    Senior Regulatory Affairs Specialist II

    1 week ago

    Grifols, S.A Clayton, United States

    Select how often (in days) to receive an alert: · Create Alert · Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been work ...

  • PSI CRO

    Regulatory Affairs Specialist

    3 weeks ago

    PSI CRO Durham, United States

    Job Description · Job DescriptionCompany Description · PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time se ...

  • GRIFOLS, S.A.

    Regulatory Affairs Specialist I/Sr. Regulatory Affairs Specialist I

    3 weeks ago

    GRIFOLS, S.A. Clayton, United States

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...

  • GRIFOLS, S.A.

    Reg Affairs Specialist I/Sr. Reg Affairs Specialist I

    3 weeks ago

    GRIFOLS, S.A. Clayton, United States

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...

  • Bioventus

    Senior Regulatory Affairs Specialist

    1 week ago

    Bioventus Durham, United States

    Senior Regulatory Affairs Specialist page is loaded · Senior Regulatory Affairs Specialist · Apply · locations · Durham, NC · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · R · Are you ready to work for a more active world? · At Bioventus ...

  • GRIFOLS, S.A.

    Regulatory Affairs Specialist I/Sr. Regulatory Affairs Specialist I

    3 weeks ago

    GRIFOLS, S.A. NC-Clayton, United States

    · Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the w ...