Prin Clin Eval Med Writer

Medtronic•Lafayette, CO

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Principal Clinical Evaluation Medical Writing to support highly complex CE deficeiences, audits, complex CE documents. This requirs a deep comprehensive understanding of EU MDR and CE experience. Advanced degree with >7 years or more experience. Responsibilities may include the following and other duties may be assigned. Review and summarize scientific literature. Reports instances of complaints/adverse events from literature to GCH. Create responses for audit/submission queries. Maintains database of peer-reviewed literature. Appraise, analyze, summarize, and discuss clinical evidence from all the available sources. Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Develop state of the art on product family for its intended purpose. Create & maintain plans and reports for regulatory authorities. Review/approve other documentation for device development. Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Requirements

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
May have broad knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Review and summarize scientific literature.
Reports instances of complaints/adverse events from literature to GCH.
Create responses for audit/submission queries.
Maintains database of peer-reviewed literature.
Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
Develop state of the art on product family for its intended purpose.
Create & maintain plans and reports for regulatory authorities.
Review/approve other documentation for device development.
Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)