Asian Regulatory Affairs, Latin America/Caribbean Regulatory Affairs, Medical Device, Quality/Risk Management
4 Year Degree
The Regulatory Affairs Specialist is responsible for preparing and coordinating regulatory submissions in accordance with Nonin policies and procedures on a world-wide basis. This person will work closely with the product development teams to develop and provide timely and accurate regulatory requirements, submission strategies and guidance for new products and product modifications. This position works closely with regulatory authorities to assure that Nonin products comply with regulatory requirements and are approved in a timely manner.
Essential Job Functions:
Prepare and maintain U.S. regulatory submissions for product approval and/or marketing clearance.
Prepare and maintain international product submissions to meet registration, licensing, certification and approval requirements.
Monitor international regulatory changes and communicate appropriate information and actions throughout the company.
Identify, understand and apply worldwide regulatory laws and regulations to our business.
Evaluate changes to product design and labeling and maintain a documented regulatory history of compliance for the life of our products.
Establish /maintain policies and procedures that detail the conduct of regulatory activities at Nonin Medical Inc.
Assist in the development of the regulatory budget.
Meet defined goals and objectives through own initiatives, activities and available resources with minimum of supervision.
Develop and communicate regulatory requirements to product development teams and work closely with the team(s) to assure compliance with and understanding of all regulatory strategies.
Perform reviews of labels, labeling, literature, and web site for accuracy, consistency, and regulatory compliance.
Provide regulatory support for product complaints and worldwide adverse event reporting requirements.
Required Education & Experience:
Bachelor’s in engineering, biological sciences, medical or related
Minimum 3 years’ experience in preparing and executing regulatory submissions on a world-wide basis or equivalent combination of education and experience.
Provide regulatory support for product complaints and world-wide adverse event reporting requirements.
Required Knowledge, Skills & Abilities:
Ability to manage multiple projects and priorities with minimal supervision.
Ability to communicate effectively across departmental lines and in a professional group environment.
Strong communication skills – written, verbal and presentation skills.
Strong computer and software experience with proficiency using Microsoft Office (Word, PowerPoint, Excel, and Outlook).
Experience in and knowledge of international registration, licensing and regulatory affairs.
Regulatory experience in medical electrical device industry
Ability to sit, and/or stand for 8 hrs/day.
Nonin offers an excellent total compensation package including competitive salaries, comprehensive benefits with medical, dental, vison, company paid life, AD&D, short and long term disability, profit sharing and a 401(k) contribution.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.
Internal Number: 2019-1268
About Nonin Medical Inc
Nonin Medical, Inc. is a growing medical device manufacturer focused on noninvasive Technologies and solutions. As the company that invented fingertip pulse oximetry, Nonin Medical has been an industry leader in noninvasive monitoring for more than 30 years. We apply innovative signal processing and sensor design technologies to create solutions that advance industry standards and meet customer needs. Our proprietary technologies and reliable devices deliver consistent measurements for medical professionals around the world.