Associate Director of Clinical and Regulatory

NeuSpera Medical is seeking a senior level candidate with clinical, regulatory and medical device experience. The qualified candidate will be capable of developing and managing new study plans, generating regulatory submissions, medical writing of study results and healthcare economics analyses in support of obtaining reimbursement coverage. The ideal candidate will have experience in all of the above areas with an implantable medical device application background. The candidate should be capable of directing and collaborating with outside entities such as a clinical contract research organization (CRO).

Longer term the candidate will develop a small internal field clinical organization that operates through a through a CRO. Familiarity with ISO 14155 and 13485 is a plus. Experience in the interface with physicians and investigators is strongly desired.

Location: NeuSpera Medical, Inc. Head Quarters in San Jose, CA

Reporting To: 
Vice President of Clinical Regulatory, NeuSpera Medical, Inc.

JOB SNAPSHOT

Base Pay: Negotiable
Employment Type: Full-Time
Job Type: Clinical Regulatory
Education: BS BME Degree; MS Preferred
Experience: >10 years
Manages Others: Not initially
Industry: Medical Devices
Required Travel: Up to 20%

JOB DUTIES & FUNCTIONS:

  • Clinical Protocol Writing: With a strong understanding of ISO 14155
  • Device Dossier Writing: With a strong understanding of ISO 14155
  • Interface with Investigators: Obtain and integrate study design feedback from the Scientific Advisory Board, existing and potential investigators
  • Interface with CROs: Provide management support for the clinical monitoring and data management functions contracted through a CRO
  • Clinical Research: Generate literature summaries on innovative neuro stimulation research and new neuromodulation indications
  • Field Clinical Organization: Planning and execution for the development of a small internal field clinical organization
  • Regulatory Submissions: Generate Q-Sub, IDE and PMA packages for FDA submission
  • Notified Body Submissions: Support Clinical Pathway Reviews and ISO 13485 certification
  • Interface with Quality Systems: Generate regulatory interface with the existing quality system
  • Respond to Regulator Questions: Provide support during and after regulatory audits
  • Study Abstracts and Manuscripts: Generate clinical evidence that can be submitted for publication in support of the Publications Plan
  • Interface with Marketing: Generate claims and messages in support of overall marketing project
  • Reimbursement Support: Generate health economics and outcomes (HEOR) evidence in support of existing reimbursement codes, or the generation of new codes, or for the extension of existing coverage
  • Intellectual Property: Generate new invention disclosures based on clinical experiences and observations
  • Program Management: Provide project management interface including project plans and timelines in support of the overall Program Management function
  • Continuous Improvement: Continuously improve clinical and regulatory interfaces with outside
  • Contribute to a goal oriented collaborative productive work environment
  • Other responsibilities such as systems engineering testing in support of verification and validation

JOB REQUIREMENTS

Associate Director

Qualifications and Experience:

  • B.S. Biomedical Engineering (MS or PhD is a plus)
  • Demonstrated experience in medical device research, clinical affairs and regulatory affairs
  • Results driven, collaborative team player capable of working well with others
  • Ability to listen to investigators and translate into accurate actionable study protocols
  • Familiarity with medical device clinical investigational standards such as ISO 14155
  • Strong verbal and medical writing communication skills

Apply Now

DOWNLOAD Associate Director of Clinical and Regulatory.pdf

Apply by email: careers@neuspera.com