[Hiring] Clinical Affairs Specialist III @Integer Holdings Corporation

Role Description

• Adhere to Integer Core Beliefs and Values, including all safety, environmental, security, and quality requirements.
• Contribute to global clinical strategies to support clinical evidence requirements for product submissions and post-submission activities.
• Represent the Clinical Affairs function on product development teams.
• Work directly with representatives from cross-functional areas in possibly multiple geographical locations.
• Ensure clinical data integrity in support of the quality and regulatory functional group needs.
• Use software to appraise, analyze, and evaluate clinical and state-of-the-art data to generate appropriate clinical evidence.
• Generate interim and final reports.
• Support Integer initiatives with the development and upkeep of market-specific clinical training.
• Support investigator conferences to review findings and advise on direction.
• Interface with and assure training of investigators/physicians, center staff, and Integer Clinical Affairs staff.
• Support adequate monitoring on all clinical trials.
• Provide a clinical perspective and approval on field complaint investigations.
• Work with regulatory bodies to facilitate regulatory approvals and queries.
• Support the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept research through post-market commercial phases.
• Perform other functions as required.

Qualifications

• Degree from higher education (Science, Engineering, Health Science, Nursing, or related field).
• 3 years of documented professional experience; or 5-7 years if a degree is not a prerequisite.
• Experience in the medical device or pharmaceutical industry including US and international medical device regulatory submissions/approvals.
• Experience with implantable devices and/or other high-risk device types.
• Suitably qualified as per MEDDEV 2.7.1 (rev 4), section 6.4 with experience in research methods, information management, literature reviews, and technical writing.
• Knowledge and experience of clinical evaluations.
• Knowledge and experience with various medical device regulations and standards guidance documents.
• Experience working with the medical community including physicians.
• Knowledge of feasibility, pivotal, and post-market clinical trials.
• Ability to work independently as well as collaboratively within the organization.
• Good written and oral communication skills, including the ability to assist in teaching and training less experienced associates.
• Experience working in ERP systems (such as Oracle, Reliance, etc.), Minitab, Excel, etc.
• Leadership skills with demonstrated ability to drive positive results and deliver projects on time and within budget.

Requirements

• Safety is the highest priority; active support of the Integer Environmental, Health Safety programs.
• Defined Goals and Objectives specifying key projects and expected milestones.
• Ensure clinical data arguments in clinical evaluation documents are sufficient to support regulatory product approvals.
• Support revenue growth by leveraging clinical knowledge for growth team initiatives.
• Creation of market-specific clinical training.
• Ensure documentation and data reflect State of the Art.
• Maintain State of the Art clinical processes underpinned by current knowledge and insight.
• Support the development and maintenance of the physician advisory board and its functions as directed.
• Complete clinical inputs for product approval and product renewal within budget.
• On Time Delivery of projects impacted by results you are involved in, delivered by specified milestones.
• Your expertise and collaboration with others to deliver results will be considered.

Benefits

• Salary range: $75,750 - $111,000.
• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility to participate in the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company-designated holidays per year plus an annual allotment of paid time off.

Company Description

• Integer creates a culture that unifies and embraces uniqueness for long-term success.
• Values embedded in everything we do include Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity.