Regulatory Affairs Specialist II
4 weeks ago
The Regulatory Affairs Specialist II (RASII) supports the regulatory team in accomplishing its tasks and achieving its goals. The RASII remains current regarding new and existing regulatory requirements of medical device manufacturers both nationally and internationally. This position is responsible for adherence to the MIM Software Quality System.
What You'll Do
- Manages international and domestic filings and registrations, including drafting and compiling all materials required in regulatory submissions, technical files, license renewal, and annual registrations.
- Coordinates with cross-functional team members on product changes, regulatory notification and approval requirements, and solving regulatory issues.
- Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy.
- Work on MDR (Medical Device Regulation) technical files and change notifications or Design History Files.
- Collaborates on initiatives to improve the quality of products, processes, and procedures.
- Obtain on-the-job training regarding industry practices and all federal and international regulations affecting MIM Software's medical device products.
- 4 plus years of knowledge and experience in regulatory preferably in the medical device field
- Bachelor's degree in Science, Engineering, or a related field is preferred.
- Must be highly organized, possess excellent written and verbal communication skills, and have the ability to multitask.
- Must be detail oriented, and able to perform work independently with minimal supervision
- Hybrid work environment so you can work remotely as well as enjoy the office
- MIM pays 100% of your insurance monthly costs; including medical, dental, vision, disability, and life insurance
- Each employee received a Health Savings Account (HSA) that fully covers the medical deductible
- 20 vacation days and 11 paid company holidays, including the time between Christmas and New Year
- A 401(k) with a 4% match that is 100% vested on day one
- Annual Bonus ProgramUp to $8,000 in continued education costs annually
- Relaxed office setting where jeans are the norm
- Free snacks and beverages at the office
- 24 hour access to an in-office fitness center
Wait, what does MIM do?
MIM provides medical imaging software to imaging centers, hospitals, specialty clinics, research organizations, and pharmaceutical companies across the globe. Our mission is to enhance patient care by providing tools to support the diagnostic and treatment process so the physician can focus on the patient.
Diversity Equity and Inclusion
MIM is committed to fostering a diverse and inclusive culture where everyone can contribute and thrive. We'll encourage, support, and learn from each other's perspectives. This is both the right thing to do and vital: diverse perspectives fuel innovations that enhance patient care.
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