Essential Duties & Responsibilities:
1. Preparation of regulatory documents or submissions for new products being developed and changes to current products
2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
3. Coordinate, prepare, or review regulatory submissions for domestic or international projects
4. Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures
5. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
6. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
7. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
8. Determine the types of regulatory submissions or internal documentation that are required for proposed device changes or labeling changes
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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https://insightglobal.com/workforce-privacy-policy/ .
2-5 years of experience with international regulatory submissions/registrations with a Bachelors Degree in Sciences or related field
Knowledge of regulatory requirements for Class I and Class II devices
Experience with FDA and EU (specifically IVDR) regulations
Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices, 21 CFR Part 820. ISO 14971 and ISO 13485
Knowledge of basic lab equipment and analytical instrumentation
Proficient in MS Word, Excel, Outlook
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.