Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Manager Regulatory Affairs
Job details
Job Type: Full-time
Number of hires for this role:1
Qualifications
Full Job Description
Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.
The Regulatory Affairs Manager will prepare and submit regulatory agency applications, reports, or correspondence with minimal oversight and will report to the Sr. Director of Regulatory Affairs at Rion.
Responsibilities:
· Maintain regulatory or compliance documentation including communication logs. Identify regulatory compliance problems / recommend solutions
Qualifications:
Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.
We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:
Full Health, Dental and Vision Insurance for employees and their dependents.
Health Insurance including PPO or High Deductible Health Plan with Health Savings Account.
Dental Insurance
Vision Insurance
Flexible Spending Accounts (FSA)
401K or IRA Retirement Savings
Life Insurance basic life and supplemental life insurance options for self, spouse, children
Short and Long-Term Disability Insurance
Paid Time Off
Paid Holidays
Parking benefits
Rion is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
Benefits:
Work Location:
Work Remotely:
Job Type: Full-time
Pay: From $113,018.00 per year
Benefits:
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Ability to Relocate:
Work Location: Hybrid remote in Rochester, MN 55902