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Regulatory Compliance Specialist

2 months ago

Cincinnati, Ohio, United States TEPHRA Full time
Position Overview:

The selected candidate will collaborate with clients and internal teams to provide exceptional solutions for regulatory submissions.

Support the development of technical documentation (including technical files and design dossiers) for Spine products that comply with the new Medical Device Regulation (MDR) in the European Union.


Key Qualifications:
  • In-depth understanding of EU Medical Device regulations and associated guidance documents, along with relevant standards.
  • Proven experience in preparing Technical Files and technical documentation for submission to notified bodies.
  • Ability to engage effectively with cross-functional teams, including R&D, Quality, Labelling, Sterility, Medical, and Clinical departments.
  • Familiarity with Product Lifecycle Management (PLM) systems such as Agile and Windchill.
  • Proficient in Microsoft Office Suite, including Word, PowerPoint, and Excel.
  • Strong communication and interpersonal skills.
  • Capable of managing multiple priorities while maintaining attention to detail.
  • Experience coordinating with offshore teams, particularly with teams in India.
Responsibilities:

  • Identify reference materials for technical documentation, including design and risk documents, verification/validation documents, standards compliance, and labeling.
  • Ensure adherence to policies, procedures, and work instructions that support technical documentation efforts.
  • Assist in the preparation of Clinical Evaluation Reports, including necessary documentation references.
  • Align technical documentation with the OneMD structure as proposed by the MDR team.
  • Prepare technical documentation for submission to and review by Notified Bodies as necessary.
  • Facilitate global product registration activities by compiling relevant dossiers, submissions, and responses to regulatory authorities.
  • Maintain up-to-date information on global regulatory requirements and the status of product registrations.
  • Ensure compliance with timelines and achievement of milestones.
Reporting:
Communicate issues to management to ensure proper resolution.

Education:
BS Degree
Experience:
4-10 years in a relevant field.