Regulatory Affairs Director

Description

Purpose

Responsibilities

• Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries.
• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
• Maintain regulatory files. Maintain and update regulatory authorizations, such as 510(k)s, medical device licenses, certificates, and CE Technical Files for EU, etc.
• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
• Assist in preparing response to regulatory authorities’ questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
• Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

Requirements

• Bachelor’s degree in Engineering or Science or related scientific discipline.
• 4 years minimum experience in a medical device environment
• Working knowledge of regulations, standards and guidelines related to regulatory affairs
• Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
• Excellent written and verbal communication skills with the ability to listen, articulate and advocate
• Proactive, high performance, result oriented and manage projects with ethical integrity
• Technical system skills (e.g. MS office applications, databases, efficient online research)
• Manage multiple projects and deadlines
• Ability to identify compliance risks and escalate when necessary
• Demonstrate both creative and critical thinking skills

Salary & Benefits

The estimated hiring salary range for this position is $150,000-$175,000.* The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental and 401K retirement plan.