Seeking a detail-oriented and collaborative Regulatory Affairs Specialist II to support global registration efforts and ensure compliance with international medical device regulations. In this role, you will work closely with internal teams and international affiliates to coordinate regulatory submissions, maintain documentation systems, and manage global requests such as Certificates to Foreign Government (CFGs), Free Sale Certificates (FSCs), and Letters of Authorization. This position plays a critical role in developing and reviewing regulatory documents, labeling content, and standard operating procedures to maintain product registrations and support business objectives worldwide.
location: Lake Forest, California
job type: Contract
salary: $35.00 - 49.27 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- 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.
- 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.
qualifications:
- Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
- 2+ years of Regulatory Affairs experience
- Strong communication skills, both written and verbal.
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
