The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Fang Consulting specializes in Medical Device Regulatory Affairs and Quality Consulting; we are headquartered in Minnesota’s Medical Alley and have a global reach of connections and clients.
We’re committed to finding an experienced, collaborative Regulatory Affairs professional who brings to work each day his/her unique perspective and drive to serve as a trusted partner to help solve our clients’ biggest challenges.
If you are interested in working in a dynamic atmosphere—our work is serious but our office is fun—and can flex to meet the demands of our emerging and Fortune 500 clients alike, we’d love to hear from you!
What you will do:
Prepare US and OUS regulatory submissions: 510(k)s, IDEs, PMAs, Technical Files and Design Dossiers
MDD to MDR gap analyses and remediation
IVDD to IVDR gap analyses and remediation
Perform detailed RA assessment of change: ECO/DCO/MCO, etc.
Review and assess changes to the design, manufacturing, and labeling for impact to product approvals/submissions
Develop global regulatory strategies for new product introductions as well as existing product changes
Global registration guidance and support
Act as regulatory representative on product development teams
What we're looking for:
A Bachelor’s degree within a scientific or technical discipline; Master’s degrees are nice too
2-5 years of Regulatory Affairs experience specifically within the medical device industry, experience with Class II and Class III devices and IVDs strongly preferred
Developed working knowledge of current and evolving domestic and international regulatory compliance requirements
Proficient in technical writing with a relentless attention to detail
Flexibility; someone who embraces change because things move quickly around here
Strong communicator who actively asks and answers questions
As cliché as it sounds, MUST LOVE DOGS
What we offer:
Competitive compensation, including 401(k) match, paid vacation and holidays
Medical and dental insurance; company-paid LTD, STD, and life insurance
Flexible working hours
Continued education—tuition reimbursement for career development courses
Lunch provided every day
Internal Number: 1
About Fang Consulting
Fang Consulting is headquartered in Minnesota’s Medical Alley with a widespread, global network of resources and connections. Our team of medical device experts use their extensive knowledge of the most current and ever-evolving US & international regulations to provide comprehensive premarket and postmarket support to our startup and leading medical device clients. Our regulatory and quality teams have the experience to mitigate risks and ensure our clients obtain the clearance to sell both new and existing products in any market with completely customizable onsite and remote support, ranging from regulatory and quality staff augmentation to auditing and project work.