Project Manager, Regulatory Affairs Job at MicroVention, Inc.
Responsible for preparing strategy for worldwide product approval submission activities, responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:
- Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
- Identify regulatory requirements for the markets identified in the regulatory strategy.
- Develop and execute the regulatory strategy and plan for assigned projects.
- Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Communicate with regulatory agencies on administrative and routine matters.
- Document, consolidate, and maintain verbal and written communication with the regulatory agencies.
- Review change order documents and ascertain impact on current regulatory approvals.
- Review promotional material and labeling for regulatory compliance.
- Develop and maintain regulatory files and records.
- Support and contribute into developing, editing, or revising regulatory processes.
- Support training for global regulatory processes and system implementations.
- Build team cohesiveness by influencing and mentoring team members.
- Perform additional responsibilities as assigned.
Qualifications
- Minimum BA/BS degree or higher.
- Five (5) to eight (8) years of professional regulatory experience.
- Strong technical writing skills as evidence by multiple 510k submissions, PMA Supplements, Technical Documentation and/or clinical study protocols/reports.
- Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
- Experience in leading moderate sized teams.
- Strong written and verbal communication skills.
- Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams.
- Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
- Experience in 510(k), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications submission.
- Experience in leading project teams.
- Ability to work well in a team environment.
- Detail oriented.
- Proven analytical abilities and organization skills.
- Ability to comprehend technical documents and concepts.
Posting Country
US - United States
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