Randstad is the #1 HR Services Company in the world and we are sourcing for a Regulatory Specialist in the Western Suburbs of Chicago, IL. The Regulatory Specialist will report to the Director of Regulatory and Quality Affairs. As the Regulatory Specialist you will be responsible for scanning and staying current in the regulatory environment. Your skills in receiving, documenting and disseminating information from a variety of regulatory bodies will make you a go-to team member as you work across departments ensuring that we are compliant in our geographies and markets. This is a direct hire position, no relocation is offered and it can start immediately.
location: Itasca, Illinois
job type: Permanent
salary: $72,000 - 78,000 per year
work hours: 8 to 4
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and assist to ensure that they are communicated through corporate policies and procedures.
- Work with the Regulatory management to determine effective regulatory pathways for a variety of issues.
- Stay informed of changing regulatory requirements and proactively work with management to plan and address such changes.
- Prepare and update technical documentation for non-US countries as necessary to obtain and sustain device approval and licensing.
- Determine the types of regulatory submissions or internal documentation for proposed device changes or labeling changes.
- Interface with various departments to collect and organize required documentation for regulatory submission.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Support regulatory inspections and provide post-inspection follow-up information as requested.
- Bachelors degree in Life Sciences, Biotechnology, Engineering, or equivalent.
- Familiar with current FDA/International regulatory requirements for medical devices.
- Three - five years in Regulatory Affairs, preferably in sterile medical devices.
- Experience with sterile medical devices standards and regulations 21CFR820, : EU 2017/745, ISO 13485:2016 and other country-specific regulations such as Brazil, China, Canada, and Australia.
- Experience with managing labeling, advertising and marketing material changes to ensure accuracy and regulatory compliance.
- Experience with complaint handling process and determining the regulatory reportability and electronic submission as required by MDR and AERS to the FDA and other regulatory bodies.
- Experience with electronic registration submissions preferred.
- Problem solving and critical thinking skills combined with the tenacity to see an issue through to a full resolution.
- Complex problem solving skills that lead to seeking out and applying the appropriate information leading to the successful implementation of solutions.
- Excellent communication skills and finesse in dealing with difficult situations.
- Bilingual or multilingual a plus (Portuguese, French, Spanish, Mandarin - Chinese).
skills: CMC, 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.