Job Title: Regulatory Affairs Associate
Duration: 12 Months (Potential Extension)
Location: Hybrid in Lake County, IL 60045
Experience Level: 3–5 Years

Job Responsibilities:

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.

 
Project Background:
A new manufacturing site in France has been added due to the acquisition of a new business. A contractor is required to complete three separate projects for CMC clinical/regulatory submissions. These are previously committed deliverables from a prior company.
Requirements:

• CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions.
• IND/IMPD submission background based on manufacturing batch records.
• Early Phase CMC knowledge is a plus.
• French/English speaking is a plus.

Preferred Qualifications:

• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices.
• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements.
• Knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks.
• May lead and direct the work of others.
• A wide degree of creativity and latitude is expected.

Top Required Skills, Experience, and Education:

1. Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
2. Technical writing skills.
3. Familiar with typical manufacturing processes, especially cell cultures.
4. Familiar with microbial methodology.
5. Familiar with ICH and country regulatory procedures for clinical trials.
6. Able to work with electronic systems, i.e., Microsoft and dossier publication systems.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $45.00/hr.