Regulatory Affairs Specialist

4 weeks ago


Upper Marlboro, Maryland, United States Connexion Systems & Engineering, Inc. Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Connexion Systems & Engineering, Inc. The ideal candidate will have a strong background in regulatory affairs and a proven track record of ensuring compliance with industry regulations.

Key Responsibilities
  • Prepare and compile document packages for regulatory submissions, audits, and inspections.
  • Participate in technical review of data or reports for incorporation into regulatory submissions.
  • Manage and maintain regulatory databases and technical files.
  • Participate in internal and external audits and investigations.
  • Review materials such as labeling, marketing materials, or user manuals to ensure compliance with regulatory agency requirements and laws.
  • Manage labeling and unique device identification requirements.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
  • Provide high-level regulatory support on projects and cross-functional teams.
  • Provide technical guidance on design reviews and regulatory strategies for product approval.
  • Contribute to developing or improving processes, procedures, and standards that contribute to meeting internal SOPs, regulatory, and industry regulations.
  • Maintain current knowledge of existing and emerging regulations, standards, and laws.
  • Administrative Responsibilities include attending all meetings, reviewing and responding to emails and other messaging platforms.
Qualifications
  • Bachelor's Degree (Engineering, Biomedical, or related field preferred), May have Master's Degree, May have PhD.
  • 5-8 Years, Higher education may compensate for years of experience.
Required Skills
  • Excellent communication, including verbal, technical writing, interpersonal, and presentation skills.
  • Proficient with technology applications such as MS Office.
  • Experience with the creation of technical files and documentation.
  • Experience working in regulated medical device industry.
  • Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA, and foreign regulatory requirements.
  • Strong data and statistical analysis skills and ability to use data to make informed recommendations.
  • High degree of attention to detail.


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