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Project Manager, Regulatory Affairs

Company Name: MicroVention-Terumo
Location: Aliso Viejo, CA
Job Type: Full-Time
Contact Name: Please apply online using the following link: http://bit.ly/2rW8rm8
 

Job Description

MicroVention-Terumo. Innovation Starts With You. The Project Manager, Regulatory Affairs position is responsible for obtaining regulatory approvals, and ensures compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements.

Typical duties:
- Serves as a member on project teams.
- Identifies regulatory requirements in each country.
- Develops worldwide regulatory strategies.
- Prepares, reviews and files worldwide regulatory submissions and dossiers to ensure MicroVention devices are commercially available in the U.S. and international markets based on the organization’s objectives.
- Communicates with regulatory agencies on administrative and routine matters.
- Documents, consolidates and maintains oral and written communication with the regulatory agencies.
- Develops and maintains regulatory files and records.
- Reviews change order documents and ascertains impact on current regulatory approvals.
- Reviews promotional material and labeling for regulatory compliance.

Job Requirements

Required Qualifications
1. BS/BA degree in Science, Engineering or Medical Technology
2. A minimum of five (5) years of experience in medical device industry.
3. A minimum of five (5) years of Regulatory Affairs experience.
4. Extensive experience in preparation of U.S. and international regulatory submissions including 510(k), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Pre-Market Approval (PMA) and Design Dossier applications. Experience with Combination Device submissions is a plus
5. Proficient computer skills (i.e. MS Office)

Desired Qualifications
1. Excellent leadership skills.
2. Ability to work well in a team environment.
3. Proven analytical abilities and organization skills (attention to detail)
4. Ability to comprehend technical documents and concepts.

Additional Information
- The primary work location for this position is Tustin, CA (the company will be relocating to a new facility in Aliso Viejo, CA in June 2017).
- Relocation may be available for qualified candidates.
- Candidates must be eligible to work in the U.S. and not require visa sponsorship.
- For more information, visit our web site at
www.microvention.com


Please apply online using the following link: http://bit.ly/2rW8rm8