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, Submission & Registration
4 Year Degree
Primary Objective: This position 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; this position also liaisons with third-party, external clinical experts for strategic clinical feedback.
Essential Job Functions:
Serve as the senior most shared regulatory resource subject matter expert across Nonin’s product portfolios.
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 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.
Serve as the liaison between Nonin and third-party CROs or MROs, as needed.
Mentorship and coaching of junior team members.
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).
Experience in and knowledge of international registration, licensing and regulatory affairs.
Ability to sit, and/or stand for 8 hrs/day.
Nonin offers an impressive 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 generous 401(k) employer match.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.
Internal Number: 2021-1407
About Nonin Medical
Nonin Medical invented finger pulse oximetry and is a global leader in developing highly accurate noninvasive medical monitoring solutions that improve the quality of people's lives. Technology driven, we provide pulse and cerebral oximeters, capnographs, sensors, OEM/eHealth, and veterinary solutions that meet customers'? needs today and tomorrow.
Nonin Medical is headquartered in Plymouth, Minnesota, USA, and has an additional customer service center in Amsterdam, the Netherlands. We sell our products to clinicians and consumers in more than 125 countries and have more than 200 OEM partners worldwide.