consulting full time legal senior

Job Details

Principal Duties and Responsibilities

  • Develop positive relationships with clients, as well as with NAMSA colleagues.
  • Ensure that products and deliverables are of high quality given time and budget constraints.
  • Function at a level that affords respect by internal NAMSA Associates/team members.
  • Communicate project/team issues to Project Manager and /or Manager.
  • Function as a productive project team member.
  • Perform project in compliance with regulations and NAMSA policies and procedures.
  • Establish and ensure schedule, budget and quality commitments are met for the client.
  • Manage (motivate, communicate) internal team members.
  • Understand investigational product(s) and high level understanding of the Medical Device Development Process.
  • Handle challenging and/or novel situations. Uses judgment to determine when issues should be escalated.
  • Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
  • Deliver... presentations, including preparation of slides, and speaking.
  • Coordinate, write, review and/or submit regulatory submissions (including but not limited to pre-submission meetings, IDEs, 510(k), and Technical Files, Design Dossiers, etc.).
  • Write, review, and assess test protocols and reports.
  • Coordinate, write and review regulatory assessments.
  • Assist clients in identifying required pre-clinical testing.
  • Perform literature reviews.
  • Develop regulatory strategies and participate in domestic (consultant’s home region) regulatory agency meetings with clients.
  • Identify and interpret Standards and Guidance Documents applicable to medical devices.
  • Able to professionally interact directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings.
  • Current, working knowledge of medical device regulations and/or biologics regulations, i.e. US FDA 21 CFR, European regulations (i.e. MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, NMPA, MHLW, any other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
  • Ability to assess regulatory impact of design and/or manufacturing changes.
  • Draft and/or evaluate regulatory SOP’s and WI’s.
  • Prepare white papers detailing current Regulatory topics.
  • Research laws and regulations for international countries, as needed.

Qualifications and Skills

Requires a minimum of

  • Bachelor’s degree or equivalent experience in a related field, with a minimum of 10 years of relevant experience or Advanced Degree (Masters or PHD) and a minimum of 5 years of relevant experience; and
  • Regulatory experience in the medical device industry is REQUIRED
  • Strong written, verbal communication and interpersonal skills.
  • Problem solving and/or troubleshooting experience.
  • Project management experience, a plus.
  • Fluency in English and local language, if different, required.
  • We are unable to support a candidate on OPT or H1B

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