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Principal Clinical Affairs Specialist

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Location
MN
Job Type
Direct Hire
Date
Dec 13, 2018
Job ID
2624667
Our mid-sized, private equity-backed global client is adding a Principal Clinical Affairs Specialist.  The candidate will be working with life-saving medical device technology development and commercialization.  The company has a rich history of innovation as well as a recognizable brand in their segments of the industry.  This global business sells their products directly in addition to utilizing a wide array of distributors around the world.  With a strong platform, new products under development and a growing global commercial presence, the organization is poised for rapid growth over the next 3 – 5 years. This is a remote position with about 20-30% travel. The ideal candidate will live in Minnesota, Wisconsin or Chicago.
 

Your role with the company:

The Principal Clinical Affairs Specialist is the company’s primary clinical expert responsible for ensuring products are adequately designed to meet their intended clinical use and for ongoing evaluation of product performance through regular evaluation of surveillance data. This includes planning and oversight of clinical studies including post-market studies, primary authorship of clinical material for submissions, interaction with world-wide regulatory agencies including the US FDA related to clinical questions, participation during inspections and audits, preparation of clinical material for FDA Annual Reports/CERs, participation on change control boards for review and approval of change requests, review of advertising and promotion materials, and review of complaints for event reporting determination.  This individual will work closely with Regulatory Affairs, R&D, Manufacturing, Quality, Marketing and other functions.
 
Essential Responsibilities: 
  • Establishing and overseeing the Clinical Affairs policies and procedures throughout the company.
  • Authoring functional strategic plans to support organizational goals and provide guidance to functional areas concerning clinical requirements, claims, clinical studies and relevant external communications.
  • Reviewing complaints for reporting determination and identifying information useful to improve products and processes.
  • Evaluation of all available clinical performance data on our products to identify trends.
  • Lead the interaction with regulatory agencies globally on clinical topics.
  • Prepare all clinical elements for regulatory submissions and reports that are required to be submitted to regulatory agencies on an ongoing basis.
  • Participation on ad/promo, change control boards, new product development teams, and product support teams to ensure clinical information is appropriately represented in decision making.
  • Building proactive relationships with external clinical experts and influencers to ensure the company remains aligned with current and changing clinical practice.
  • Actively engaging in industry organizations to stay abreast of industry changes, best practices and benchmarking to support continuous improvement opportunities.
  • Leading education of all disciplines to ensure understanding of the clinical operation, practice and impact of our products.
  • Authoring internal training materials and ensuring proper deployment company wide.
  • Authoring and maintaining training materials for end users for use by direct and contract clinical educators.
  • Collaborating with internal and external stakeholders to achieve objectives.  These groups include external customers and consumers, Sales, R&D, Quality, Manufacturing, Supply Chain and other internal and external partners.
Desired Qualifications:
  • 10+ years of experience in Clinical Affairs within the Medical Device industry.
  • Undergraduate degree required, Life Sciences related, or Engineering Undergraduate degree strongly preferred.
  • An advanced degree (MS, MBA, PhD) preferred. CCRP valued but not required.
  • Demonstrated experience with devices for defibrillation or cardiac rhythm management strongly preferred.
  • Demonstrated skill interacting with physicians and customers.
  • Experience with PMA products preferred.
  • Solid understanding of Good Laboratory Practices per 21 CFR Part 53, corporate policies, government regulations, including a thorough familiarity with Medical Device Quality System regulations and standards.
  • Knowledge of FDA 21 CFR 803/806/820 and ISO 13485 / ISO 14971 Standards and associated guidance.
  • Ability to understand issues in relation to product manufacturing operations and their impact.
  • Must demonstrate proven critical thinking, people and team development skills, strategic aptitude, and independent leadership.