Regulatory Affairs Specialist-4694 - Palo Alto, United States - Infosoft

Infosoft
Infosoft
Verified Company
Palo Alto, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
One of our clients is looking for a talented and highly motivated
Sr. Regulatory Affairs Specialist.

Please
send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title
:
Sr. Regulatory Affairs Specialist

Pay Rate
:
$63 to $68.89/HR
Duration
:12 months

Location
:
Palo Alto, CA (Hybrid - 2 days/week onsite)
This position is for the
Healthcare Diagnostics division.

We are looking for
Sr. Regulatory Affairs Specialist

  • Perform the coordination and preparation of
    regulatory submissions for brachytherapy devices and software devices according to regulatory requirements
  • Identifies, analyzes, and implements countryspecific requirements necessary for
    productrelated submissions
:


  • Performs regulatory projects or acts as a member of the project steering group.
  • Submits required documentation/information to local authorities or our internal.
  • Initiates and escalates necessary activities if deviations are identified.
  • Ensures the creation of adequate documentation for audits/inspections.
  • Performs training within the organization in countryspecific regulatory requirements, if applicable.
  • Write and maintain submission procedures, work instructions, and templates relevant to regulatory compliance.
  • Performs review of promotional material for regulatory compliance according to countryspecific requirements.
  • Is expected to adopt existing concepts, methodologies, etc. to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.

Experience:


  • 58 years of regulatory affairs relate experience
-
Product Registration Experience:


  • Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications, and EU MDR technical files.
  • Knowledge of regulatory guidance documents (
    FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
  • Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO as evidenced by coursework or submissions that required the use of each standard
  • Teamwork and collaboration:
  • Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
  • Proficient in utilizing business tools such as Email, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

Job Type:

Contract


Pay:
$ $68.89 per hour


Experience level:

  • 4 years

Schedule:

  • 8 hour shift
  • Day shift

Application Question(s):

  • This is a W2 position, Are you ok to work on W2?

Education:


  • Bachelor's (required)

Experience:


  • Regulatory Regulations (FDA, Health Canada, EU MDR): 4 years (required)
  • 510(k) submissions: 4 years (required)
  • ISO 13485, IEC 62304, IEC 62366, ISO 14971: 4 years (required)

Ability to Commute:

  • Palo Alto, CA required)

Ability to Relocate:

  • Palo Alto, CA 94304: Relocate before starting work (required)

Work Location:
In person
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