Vacancy expired!
Title : Regulatory Affairs Specialists II Location : Waukesha, WI Duration : 18+ Months Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Understanding of key business drivers; uses this understanding to accomplish own work. Understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. Develops regulatory strategies to help optimize regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Contributes to writing and editing technical documents. style="box-sizing:inherit; font-variant-ligatures:normal; font-variant-caps:normal; orphans:2; widows:2; -webkit-text-stroke-width:0px; text-decoration-thickness:initial; text-decoration-style:initial; text-decoration-color:initial; word-spacing:0px" Required Qualifications Bachelor's Degree 5 years work experience in medical device regulatory affairs. Desired Characteristics Ability to work independently in fast-paced environment with little supervision. Ability to adapt to constant change and influence positive change effectively. Team-oriented and responsive to customer needs. Ability to understand technical documentation and execute associated procedures
Vacancy expired!