Sr. Regulatory Affairs Specialist

Company Name:

Clarity Technology Partners

Job Location:

Carlsbad, CA

Position Title:

Sr. Regulatory Affairs Specialist

Position Type:

Full time

General Job Description:

We are looking for a Sr. Regulatory Affairs Specialist in Carlsbad, CA for our client in the dental industry. We have placed a number of candidates with this client and it is a great place to work, truly one of the leaders in their field! This is a full time, permanent role that comes with great benefits including medical/vision/dental insurance, PTO, 401k, etc. This role will be remote for the time being, but likely to transition to onsite in the future. As the Sr. Regulatory Affairs Specialist you will participate and manage necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European Medical Device registration. Essential Job Duties and Responsibilities: Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR. Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR). Ensure compliance with US and international regulations and guidelines. You will also provide routine regulatory support, which may include, but not limited to: Support the compilation, development, submission, and maintenance of worldwide regulatory filings -Track regulatory project status and informational documents -Create timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time -Interface with global Regulatory partners and internal cross functional teams -Attend relevant functional area and project team meetings as required.

Responsibilities:

  • Plan and prepare global regulatory dossiers with a focus on Medical Device Technical Files in accordance with MDD and MDR.

  • Assist the Regulatory Affairs Director with Regulatory activities to ensure compliance with the new European Medical Device Regulations (MDR).

  • Ensure compliance with US and international regulations and guidelines.

Qualifications:

  • Must have experience with European Regulations around Medical Devices. Ideally experience with EU Medical Device Directives (MDD) or EU Medical Device Regulations (MDR).

  • Must have experience in creating technical files as this is a part of the European registration process.

Application Information & Contact (How to Apply)

Please apply to our Linkedin job posting, or email your resume directly to Alexandra@ctpconsulting.com

Learn more about Clarity Technology Partners here.

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