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    Regulatory Affairs Senior Specialist - Raleigh, United States - Merz Pharmaceuticals USA

    Merz Pharmaceuticals USA
    Merz Pharmaceuticals USA Raleigh, United States

    2 weeks ago

    Default job background
    Description

    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 implementation of submissions under the direction of a line manager.

    Responsibilities


    • Provide ongoing support to cross functional teams to provide regulatory strategies during product development. Identify and assess regulatory risks and project issues. Make recommendations to team and regulatory management. Provide regulatory timelines to coordinate with department and corporate objectives.
    • Interact with project team members to ensure high quality and timely regulatory submissions. Preparation and coordination of submissions in accordance with the current regulations and guidance's. Ensure submissions support company objectives and strategy.
    • Interact with regulatory health agencies, contract manufacturers, affiliates and distributors as necessary. Document and archive these discussions and communicate discussions with internal stakeholders as necessary.
    • Maintain current regulatory knowledge of regulations and guidelines related to company's activities and products. Communicate to internal stakeholders the interpretation and implications of regulations and guidance as necessary.
    • Review and provide strategic regulatory input on product and package labeling as needed.
    • Provide support to other regulatory staff as needed and performs duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management. Additional duties as needed to support the business and overall company objectives
    Education


    • Required:
    • Bachelor's degree in scientific or healthcare discipline
    Professional experience


    • Required:
    • Minimum 5 years of relevant medical devices regulatory experience
    • Preferred:
    • Experience with electromedical devices
    Knowledge, skills, and abilities


    • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
    • Demonstrated success in assisting with the preparing, filing and completing of regulatory submissions.
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