Insight Global is looking for a Regulatory Affairs Specialist II to join their Peripheral Interventions team. This candidate is acting as a product owner and is responsible for regulatory affairs support on a global stance. They will work with the EU and international regulatory partners and represent regulatory on project teams. They will be apart of the product development process, integration of acquired products and ongoing regulatory compliance. This candidate will be spending 60% of their day conducting independent work, reviewing emails etc. The remainder of the time will be spent with project teams representing regulatory within R&D, PI, Vascular, and Operation's engineers. This candidate will start out by reviewing changes to existing class II and class III devices. This role has a pay range of 88-105k salary depending on experience.
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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- Bachelors degree in a scientific or technical degree. Ex: regulatory affairs, biomedical, biology, handful of technical communications, technical writing, and microbiology.
3 years of medical device experience and 2 years of regulatory affairs experience.
1 year of regulatory experience if its relevant to their risk classifications, for medical devices for class III, involved with 10k's.
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.