Clinical Safety Director-Part-Time

2 weeks ago

Irvine CA United States Ledgent Technology Full time

Provide strategic, technical, and risk/benefit decisions on behalf of MACA and partnering with Marketing, Commercial, Quality, R&D, Regulatory Affairs and others as a physician expert and ambassador for projects needing qualified medical input and activities.

Key Responsibilities:

  • Serve as an expert medical liaison between the SURG business and customers regarding our portfolio, their use in practice, and benefits as a physician expert to drive market development and adoption through evidence and education, support BD opportunity assessments, practice trends, advocacy and relevant strategic insights
  • Participate in medical risk/benefit evaluations and technical troubleshooting for Clinical Evidence Reports, safety evaluations, risk management and PMS reviews, and corrections/removals, as required.
  • Provide technical expertise to product development, professional education, design validation, RA, Quality/RM including literature review and evaluation of evidence
  • Collaborate with new product development, professional education, MKT, and other functional activities providing his/her surgical insights to support innovation, go to market strategies, evidence and claims, to challenge status quo
  • Help raise the organization's clinical acumen by providing expert guidance to Clinical Affairs, Regulatory Affairs, R&D, new product development, pre-clinical support and other teams to expand knowledge of patient disease treatments and physician expectations for product use.
  • Act as subject matter expert (or as a chairperson) in external and internal meetings and symposia by engaging stakeholders and teams where either general medical expertise is required or where specific (specialty training) medical input is required.
Other incidental duties

Education and Experience:
Doctor of Medicine in M.D. and board certification in Cardiothoracic Surgery or equivalent medical training , 10 years of previous clinical practice experience.
Experience in rules on Class II and III medical device technologies

Additional Skills:

  • Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
  • Recognized as an expert within MACA, supporting commercial, R&D, and Regulatory Affairs and broader organization with broad-based expertise across area and related functions
  • Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems
  • Expert understanding of related aspects of processes and/or systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to interact with other medical professionals to help understand product issues and identify potential solutions with appropriate internal teams
  • Have established relationships in the clinical areas of focus for Heart Valve Therapies.
  • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
  • Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Desired Skills and Experience

Roth Staffing is looking for Director Clinical Safety for our client (medical technologies firm).

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated

Los Angeles county

, to the extent our customers

require

a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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