Regulatory Affairs Director

VitalConnect; California (MO); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401K retirement plan

Job summary

VitalConnect, located in California, is seeking a Regulatory Affairs professional responsible for ensuring compliance with medical device regulations. This includes writing and analyzing technical documents for regulatory submissions and maintaining regulatory files.

The ideal candidate will have a Bachelor's degree in Engineering or Science, with at least 4 years of experience in the medical device sector. The role offers a competitive salary range of $150,000-$175,000 and various benefits including medical coverage and 401K plan.

Qualifications

• 4+ years of experience in a medical device environment.
• Working knowledge of regulations and guidelines related to regulatory affairs.
• Ability to manage multiple projects and deadlines.

Responsibilities

• Write and edit technical documents for country-specific regulatory submissions.
• Maintain regulatory files and authorizations including renewals and listings.
• Prepare responses to regulatory authorities’ questions within timelines.

Skills

Regulatory compliance knowledge

Analytical skills

Communication skills

Project management

Technical system skills

Education

Bachelor’s degree in Engineering or Science

Tools

MS Office applications

Databases

Job description

Purpose

Responsible for regulatory affairs activities such as regulatory submissions, 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.

Description

Responsible for regulatory affairs activities such as regulatory submissions, 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 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

Qualifications

• 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 elevate 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.