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.
The Sr. Regulatory Affairs Specialist is responsible for preparing and coordinating regulatory submissions in accordance with Nonin policies and procedures on a world-wide basis. This position works closely with 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.
•Assist in the development of global regulatory strategies for Nonin product(s), product families, product claims, and competitive positions.
•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.
•Initiate and/or participate in the review and development of new legislation and/or regulations and assist in the preparation of comments for submission into the promulgation process.
•Provide regulatory support for product complaints and worldwide adverse event reporting requirements.
Required Education & Experience:
•Bachelor’s in engineering, biological sciences, medical or related and minimum 5-10 years’ experience in preparing and executing regulatory submissions on a world-wide basis or equivalent combination of education and experience.
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).
•Self-Starter; Highly-Organized; Detail-Oriented; Excellent presentation skills.
•Customer-Focused; Results-Driven; Initiative; “Can-Do” Attitude.
•Experience in and knowledge of international registration, licensing and regulatory affairs.
•Ability to sit, and/or stand for 8 hours/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.