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.
Reviews and revises technical files as needed to ensure the latest regulatory requirements are met.
Interprets ISO 13485 standard, related standards, and other regulatory requirements and updates internal procedures to be compliant.
Serves as Management Representative as defined in applicable regulations and standards.
Leads all external quality audits.
Investigates and responds to customer complaints per DTI’s formal complaint handling process.
Develops product registration strategies that enable accelerated product development through knowledge of FDA regulations, EU Directives, ISO standards, etc.
Provides support on special regulatory assignments relating to the development of internal procedures, training, and interpretation of existing and new international regulations.
Plans and executes global product registrations on time.
Oversees annual FDA drug and medical device establishment registrations.
Reviews product design, label or other critical characteristics for impact on product registrations.
Reviews product labeling and claims for compliance to applicable regulations.
Assures regulatory compliance in all activities.
Complies with cGMP, EHS guidelines, and all working procedures assigned to the position.
Performs other tasks, as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
Bachelor’s degree with 3 years relevant experience or Master’s degree in related field. Regulatory Affairs Professional certification preferred.
Able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to calculate figures and amounts such as proportions and percentages.
Ability to carry out instructions furnished in written, verbal, or diagram form.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The Regulatory Affairs Associate is an exempt position that is paid semimonthly. Pay rate will be dependent on a number of factors including but not limited to knowledge, skills, and experience.
Dental Technologies Inc. is proud to be an equal opportunity employer.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Additional Salary Information: Salaried position paid semi-monthly, Medical, Dental, Vision, 401(k), and Life Insurance.
Internal Number: 101
About Dental Technologies Inc.
Dental Technologies, Inc. is a company specializing in the research, formulation, compounding and packaging of dental, orthodontic and oral pharmaceutical products. Some products include dental restoratives, core build-ups, bonding agents, orthodontic adhesives, prophylaxis paste, fluoride treatments, toothpaste and varnishes. Dental Technologies maintains the ISO 13485:2016 quality system and employs more than 70 people, with research at the focus of our strategy. Dental Technologies, Inc. is dedicated to excellence in research & development, manufacturing, in-depth testing, efficient packaging, and personalized service. With process control experts committed to the highest level of integrity, quality, and service, Dental Technologies, Inc. ensures risk free product manufacturing - See more at: www.dentaltech.com/