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Senior Regulatory Affairs Specialist Job

Job description

KEY SKILLS & EXPERIENCE
• Bachelors Degree required
• Minimum of 3-4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Experience in Medical Device or Pharma is essential
• Experience of working with regulatory files for USA / EU
• Must have led projects/programs on own initiative and filed them
• Experience working directly with FDA, and notified bodies in the Europe
• Experience working with Class III medical devices or DMS Drug master file
• Experience filing using the ECTS system
• Experience with Microsoft applications including Word, Excel, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable

Responsibilities may include the following and other duties may be assigned.
• Direct or perform coordination and preparation of document packages for regulatory submissions


• Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies


• Lead or compile all materials required in submissions, license renewal and annual registrations


• Recommend changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance


• Keep abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements


• May direct interaction with regulatory agencies on defined matters


• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed


• Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)

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