As one of the world's leading manufacturers of medical devices, Hamilton Medical Inc. is headquartered in Reno, NV, and represented worldwide by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of ventilation and changes the lives of patients every day.
We are seeking a regulatory professional for our regulatory affairs department. The regulatory affairs department is responsible for registration in highly regulated markets of the newly developed products and the existing portfolio. With newly developed innovative products, the regulatory affairs department offers an excellent opportunity to work on challenging regulatory submissions.
Defining regulatory strategy and establishing submissions up to the clearance/approval.
Device listings and maintenance of submissions.
Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the organization and project teams.
Supporting R&D, during the development phase, production, and sales organizations by providing guidance on regulatory requirements.
Excellent knowledge of the applicable medical device regulations in the countries including current developments (EU-MDR) is an advantage.
Independent, reliable, and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously.
Fluency in the English language mandatory, German and any other language an advantage.
Education and Experience
B.S. in Physical Science, Pharmacy, Pharmacology, Medicine Engineering, or related field.
Minimum of 5-10 years of experience with Class II & III medical devices (PMA 21 CRF Part 814, IDE 21 CRF Part 812, 510(k) Premarket Notification, Device Classification under Section 513(f)(2) (De Novo)) interactions with the FDA.
Minimum of 5-10 years industrial quality assurance experience and must include 3 years management at department level.
Diverse portfolio of exciting and innovative design projects
Tremendous opportunities for professional growth and advancement
Commitment to sustainable design
Excellent Benefit Package (medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and much more)
It is the policy of this organization to provide equal employment opportunities to all qualified applicants without regard to race, creed, color, national origin, sex, age 40 and over, disability, marital status, sexual orientation, gender identity, genetic information, citizenship status, religious preference, or veteran status in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations.
Hamilton Medical was founded with a vision: To develop intelligent ventilation solutions that make life safer for patients in critical care and easier for the people who care for them. Today, Hamilton Medical is a leading manufacturer of critical care ventilation solutions for a wide variety of patient populations, applications, and environments.