Regulatory Affairs Specialist II

Target Pay Rate: 43.38-49.28/hr **salary will be commensurate with experience

Job Description:
Work with global partners and support worldwide registrations efforts.
Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives.
Manages requests from regions and countries, provides responses and requested documentation (CFG's, FSC, certifications, Letter of Authorization, etc.) in a timely manner.
Prepares supporting documentation and arrange for legalizations, as required by country regulations.
Support communications with US and international affiliates and regulatory personnel.
Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
Provides high quality regulatory support for assigned products/projects.
Develops documents that are clear, concise, and complete to facilitate and maintain registration renewal, tenders, and licenses.
Prepare, consolidate, response and follow-up on change assessments for global regulatory strategies.
Review and approve labeling to ensure accuracy of content.
Maintain a current knowledge of global medical device regulations pertaining to the distribution of products, which include facility registration and device listing.
Maintain documentation and a historical record for regulatory submissions.
Notarize regulatory registration documents as necessary. Willing to obtain notary license in California.
Compile and maintain regulatory documentation databases or systems.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Support preparation of additional information or responses as requested by regulatory agencies.
Recommend changes to company procedures in response to changes in regulations or standards.
Write or update standard operating procedures, work instructions, or policies.

Must haves:
• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English
• 2 Years of Relevant Experience
• Work hours: M-F – 8am – 5pm onsite
• Travel Requirements: Minimal
• Relocation assistance: No
• Sponsorship available: No

Additional:
* Compile and maintain regulatory documentation databases or systems. * Coordinate efforts associated with the preparation of regulatory documents or submissions. * Coordinate, prepare, or review regulatory submissions for domestic or international projects. * Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. * Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. * Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. * Prepare or maintain technical files as necessary to obtain and sustain product approval. * Recommend changes to company procedures in response to changes in regulations or standards. * Write or update standard operating procedures, work instructions, or policies. * Develop or track quality metrics.