Clinical Regulatory Affairs Associate

WHAT YOU’LL DO

• May interface directly with FDA and other regulatory agencies.
• Prepares robust regulatory applications for Class II or Class III devices (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Reviews protocols and reports to support regulatory submissions.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Work with cross-functional team to support product release process.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriatepersonnel.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.Provides guidance and expertise.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to critically think through complex problem statements.
• Multitasks, prioritizes and meets deadlines in timely manner.
• BA or BS degree in atechnical discipline
• 1+ years regulatory experience
• Strong organizational and follow-up skills, as well as attention to detail.
• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.

Preferred

• Experience writing clear and concise technical documents.
• Ability to work in a broaderenterprise/cross-divisionbusiness
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to work in a highly matrixed and geographically diverse business environment, unit model.
• Ability to leverage and/or engage others to accomplish projects.