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.
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The Ormco Regulatory Affairs Associate is responsible for supporting the RA department in the preparation and organization of activities supporting regulatory compliance and submissions.
This position is responsible for assisting regulatory global submissions in support of product clearances and approvals, as well as sustainment projects, management of all licensing and applications for products.
PRIMARY DUTIES & RESPONSIBILITIES:
Works in partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance.
Responsible for authoring department standard operating procedure (SOPs).
Responsible for FDA/Canadian device/drug establishment registrations and device/drug listings (as required).
Responsible for assisting in regulatory review of product claims and literature.
Prepares monthly status reports on status of current issues to the Manager of Regulatory Affairs.
Assists with Customs requests.
Assists in the assembly of global submissions (as required).
Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA, HC, EU and ROW).
Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation.
Organize and maintain files/folders/databases for all business units to support the integrity of RA documentation.
Management of the RA department purchase credit card (p-card) and monthly reconciliation.
Coordination and submission of all purchasing requests within the RA department.
Order documents, subscriptions, articles, standards and other items.
Provide support and coordination for regulatory shipments (UPS, etc.).
Coordination of all notarization and authentication (legalization) efforts for business units done per country requirements.
Work on ad-hoc projects when required.
Facilitate and maintain the Certificate of Foreign Government (CFG) applications to FDA and Certificates of Free Sale (CFS) within the department.
Follows up on actions taken to resolve regulatory issues and ensure companywide compliance.
Reviews regulatory publications to keep apprised of new regulatory developments.
Performs special projects at the direction of the Regulatory Affairs Management.
Bachelor's Degree (BA/BS) from four-year college/university required with field of study in Regulatory Affairs or in pursuit of a degree or certification in Regulatory Affairs.
While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
1-2 years related experience and/or training; or equivalent combination of education and experience in Regulatory Affairs.
Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision
Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems.
Enthusiastic self-starter with excellent verbal, written, and interpersonal skills
Highly organized, detail-oriented “mindset” and ability to be flexible and multi-task in a dynamically changing environment.
Internal Number: R5004760
WHO WE ARE
Our roots run deep.
Envista is a global family of three operating companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its partners deliver the best possible patient care through industry-leading products, solutions, and technology.
Envista separated from Danaher as an independent entity in 2019, bringing its proven business system methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, innovation, and deep customer focus. Envista is now one of the largest global dental products companies, with significant market positions in some of the industry's most attractive segments. Our comprehensive portfolio spans innovative dental implants and treatment options, orthodontics, and digital imaging technologies.