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Medical Affairs Associate Director or Senior Manager (RI)

Confidential, RI · Healthcare
The Medical Affairs Associate Director or Senior Manager is responsible for the development and management of the clinical affairs function through in the support of our client’s Surgery product development and overall business objectives, assures compliance with applicable regulations regarding all pre-market and post-market product clinical study activities as defined within procedures.  Provides strategic direction for clinical evaluation of products in support of regulatory approval and marketing needs.   This individual is subject-matter expert in clinical affairs management and execution.
  • Utilize technical clinical affairs skills to propose strategies on complex issues.
  • Provide clinical input to product lifecycle planning.
  • Provide strategic input and technical guidance on clinical requirements to development teams.
  • Manage and execute pre-approval clinical activities.
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders.
  • Support and review regulatory submissions as required.
  • Monitor and submit applicable submissions (IDE, CTA, etc.), reports and responses to regulatory authorities.
  • Ensure compliance with product post-marketing approval requirements.
  • Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.
  • Review and approve required reports, supplemental submissions and other post-marketing commitments to   update and maintain product approvals and registrations.
  • Provide training for stakeholders on current and new clinical requirements to ensure company-wide compliance.
  • Develop and maintain ClinicalTrials.gov responsibilities for the business unit products.
  • Develop and maintain business unit SOPs/processes for clinical research.
  • Interface with Corporate Medical Affairs on developing processes and internal standards. Travel between company offices in the US (RI, NJ, IL).
  • Minimum M.S. Science, engineering, or other relevant technical degree with minimum 10 years of leadership experience in clinical affairs. Advanced degree (e.g. MPH, PhD) strongly preferred.
  • Previous experience with managing professionals.
  • Broad knowledge and experience with clinical affairs regulations and implementation.
  • Demonstrated track record of managing multiple parallel studies from initiation through completion with resulting successful marketing authorization, publications, and establishment of broadened indications and claims for medical devices.
  • Thorough knowledge of medical products quality system principles and GCP concepts, practices and procedures.
  • Ability to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.
  • Ability to work in a matrix/team environment with prior significant experience supervising regulatory affairs professionals. Solid skill in written and oral communications.
  • Positive energy and enthusiasm to work in a multi-task environment.
  • Positive energy and enthusiasm to work in a multi-task environment.
  • Existing professional and scientific interfaces with professional societies and governmental regulatory agencies.
  • Ability to travel as needed, up to 30%.
Broader Intelligence
OFFICE:  920-428-4124
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