Regulatory Affairs Specialist

Purpose

Responsible for regulatory affairs activities to assist in regulatory submission, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. Assist with post-market activities.

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 the 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.
• Other duties as assigned

Requirements

Qualificaitons

• 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 $80,000-$90,000. * 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.