We are looking for a Regulatory Affair Specialist for a 12month contract in Wauwatosa, WI. It is a remote opportunity.
• Developing global submission strategy and compliance plans for cross modality (CT, Xray, PET) programs to guide submission pathways, taking into consideration regulatory requirements and business priorities to ensure optimized sequencing for submissions.
• EU MDR transition and global regulatory assessment activities
• Perform gap assessment on 21CFR Sub Chapter J Product Reporting
• Works with a cross functional team to prioritize, produce and submit applications for the purpose of obtaining authorization for commercialization.
• Handles responses to regulator inquiries.
• Supports regulatory inspections as required.
• Bachelor’s Degree
• At least 2 years prior experience in regulated industry (Med device, Pharma, etc.)
• Proficiency in word, excel, ppt.
• Proficiency in English (spoken & written)
• Self-motivated & action oriented.
Preferred Qualifications –
• Experience with 21CFR Sub Chapter J Product reporting
Looking for Meaningful Work? We can help.
If you are a Regulatory Affair Specialist, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.
We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at firstname.lastname@example.org.
We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.