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Sr. Regulatory Affairs Specialist

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Location
MN
Job Type
Direct Hire
Date
Jan 11, 2019
Job ID
2648260
Our mid-sized medical device client is building their regulatory department and launching over 20 new products into the market!  They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment! The Sr/Principal Specialist will prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.

Your role with the company:

  • Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.

  • Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.

  • Prepare Annual PMA Report and associated PMA Supplements as required.

  • Regulatory representative on new product development teams.

  • Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.

  • Review and approve technical literature (labeling, IFU’s, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.

  • Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.

  • Review and provide oversight of FDA Drug Listings, State Distributor Licensing among State Boards of Pharmacy, and Global Product Registration in support of Direct Reports.

    Keep abreast of new and changing regulatory requirements.

  • Update RA procedures as needed to ensure Smiths Medical is in compliance with new and changing regulatory requirements.

  • Inform project teams of new and changing regulatory requirements.

  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes).

  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement

  • Review and approve engineering change orders (ECO's) ensuring compliance with FDA and international submissions on file.

  • Provide regulatory guidance on new product development and manufacturing changes to existing products.

  • Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.

  • Review and approve product literature to ensure compliance with FDA and international submissions on file.

  • Direct the development of international master files for registration of product in international markets.

Desired Profile:

Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Seven to ten years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).

  • Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but

  • Review and approve engineering change orders (ECO's) ensuring compliance with FDA and international submissions on file.

  • Provide regulatory guidance on new product development and manufacturing changes to existing products.

  • Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.

  • Review and approve product literature to ensure compliance with FDA and international submissions on file.

  • Direct the development of international master files for registration of product in international markets.