Senior Regulatory Affairs Specialist

The Impact You’ll Make in this Role
In this senior regulatory affairs position, you will have the opportunity to act as the lead for regulatory affairs on cross functional teams and have ownership of product line submissions and registrations across the globe, for the dental solutions business. The role will have a significant impact for Tier 1 country registrations in high volume markets (US, Canada, EU, etc.). The position will work with the international regulatory affairs group to ensure products are registered globally based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes to due the company spin-off.


As a(n) Senior Regulatory Affairs Specialist , you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Conducting global regulatory change assessments and coordinating associated activities for assigned products.
• Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills.
• Providing regulatory review of technical reports and documents.
• Providing contributions for development and implementation of regulatory processes.
• Documenting and managing metrics.
• Leading regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).
• Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
• Communicating results of technical tasks to teams supported, respective business group(s) and/or country/region served via reports, standards and/or presentations.
• Leading the implementation of key corporate initiatives and appropriate tools.

The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position.

A successful candidate for this role:

• Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems.
• Has exceptional attention to detail, written and oral communication skills.
• Applies methodology of process improvement when applicable.
• Utilizes strong technical and non-technical communication skills of listening, reading, writing, and speaking and continuously improves upon these skills through regular participation in appropriate training activities.
• Maintains broad knowledge of assigned organization's products, broad industry trends, and customer needs.
• Capable of developing understanding of technologies and/or products across multiple divisions.
• Possesses knowledge of and regularly utilizes available information resources and systems.
• Collaborates with colleagues to innovate, influence, and/or negotiate when required.

Your Skills and Expertise

• Bachelor’s Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering or Physics.
• 10+ years in regulatory affairs in the medical device industry
• Direct experience authoring submissions/technical documentation for US, Canada, EU and supporting EMEA, APAC and LATAM regions
• Direct experience authoring regulatory strategies and regulatory change assessments
• Direct experience revising, reviewing and approving labeling (including marketing claims) that meet global regulatory requirements
• Must have experience and expertise in design control verification and validation activities, as well as expertise in clinical requirements for medical devices; in particular, experience with assisting teams with documenting and performing to applicable requirements, and assisting with writing, reviewing and approving all protocols and reports
• Expert technical writing skills in the English language
• Experience working in the dental device field or with dental products
• Experience working with formulated products
• Experience in project management
• Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.