Job Description
Pay: up to $48/hr on w2 (no C2C or 3rd parties)
Job Title: Regulatory Affairs Specialist II
Location: Lake Forest, CA (onsite)
Work hours: M-F – 8am – 5pm onsite
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.
- Prepare 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
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.
Job Tags
Worldwide,