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    Regulatory Affairs Specialist - Exton, United States - IntePros Consulting

    IntePros Consulting
    IntePros Consulting Exton, United States

    4 weeks ago

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    Description

    IntePros is currently looking for a Regulatory Affairs Specialist with Mandarin experience to join one of premier medical device manufacturing clients in Exton, PA. The Regulatory Affairs Specialist (RA Specialist) is responsible for supporting registration of client's Administration and Safety System devices, with primary responsibility for obtaining device regulatory approvals/clearances in the APAC regions. This includes the authoring, preparation, and review of technical dossiers. The RA Specialist ensures timely execution in preparation of high-quality deliverables supporting the regulatory submission. In addition, the RA Specialist ensures submissions are compliant with clients internal processes and applicable regulatory requirements. This position includes supporting internal and external customer regulatory requests.

    Regulatory Affairs Specialist Responsibilities:

    • With management input author and review China, South Korea, Japan and additional international submissions, with guidance for new products and product changes as required to ensure timely approvals/clearance/licensure for market release.
    • Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations.
    • Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
    • Work with RA team to build regulatory strategies, including worldwide requirements lists, for Administration and Safety system device development platforms.
    • Create documentation in response to customer and regulatory agency requests, including regulatory letters, technical packages, etc.
    • Write or update standard operating procedures, work instructions, or policies with guidance.
    • Develop specific objectives and manage work assignments with guidance to achieve personal objectives in conformance with overall business goals.
    • Manage and deliver projects based on priorities.
    • Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.
    • Adhere to all applicable government regulations and client policies, practices, and procedures to maintain compliance.
    Regulatory Affairs Specialist Basic Qualifications:
    • Education: Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline
    • Experience: Bachelor's with 2-4 years; Master's degree/PhD 1-2 years medical device regulatory submission experience in the APAC region.
    Regulatory Affairs Specialist Preferred Knowledge, Skills and Abilities:
    • History of successful international APAC device registration (China, Korea, Japan, etc.)
    • Knowledge of medical device regulations in APAC regions, such as China Decree 739, Korea Medical Device Act, etc.
    • Knowledge of product life cycle, product development process, design controls, and change control.
    • Attention to detail with planning, time management, and organizational skills.
    • Experience interacting with global regulatory agencies.
    • Excellent oral communication, technical writing, and decision-making skills
    • Self-motivated with a proactive attitude and the ability to work effectively.
    • R.A.C certification(s)
    • Experience with Administration and Safety System devices preferred.
    • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.
    Travel Requirements:

    Must be able to travel up to 5-10% of the time
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