ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
What You'll Do
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.
Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.
As a key member of the team, you will play an integral part in helping Enovis drive the medical technology industry forward by transforming patient care and improving patient outcomes.
Job Title:
Regulatory Affairs Sustaining Specialist
We are the International Surgical division of Enovis™, a global innovation-driven company in the medical technology sector. Every day, we are committed to improving patients' quality of life by developing innovative and clinically differentiated solutions. We seek top talent, foster continuous innovation, and are driven by the desire to improve ourselves day by day.
We are currently looking for an experienced Regulatory Affairs Sustaining Specialist to join our Regulatory Affairs department, with a background in the medical device industry.
The ideal candidate has a scientific education and will be responsible for preparing and managing technical documentation to maintain medical device certifications in compliance with MDR regulations. This includes overseeing the change management process for products and related processes.
Main Responsibilities
- Preparation, updating, and management of technical documentation for the registration and maintenance of medical devices in accordance with Regulation (EU) 2017/745 (MDR).
- Cross-functional collaboration with product development, quality, clinical and manufacturing teams to gather necessary information for compiling technical files.
- Regulatory management of product/process changes (e.g., reportability assessment, notification of changes to notified bodies/competent authorities).
- Handling communications with notified bodies and competent authorities (e.g., responses to deficiencies and/or requests for clarification).
- Contribution to the analysis of deficiency reports and preparation of responses.
- Active participation in defining and improving internal regulatory management processes (e.g., structure of technical documentation, notification processes).
Requirements
- Degree in scientific disciplines (Biology, Chemistry, Biomedical Engineering, or related fields).
- At least 1–2 years of experience in Regulatory Affairs within the medical device industry.
- Knowledge of MDR and major international regulations applicable to medical devices.
- Good time and priority management skills.
- Excellent command of English (B2/C1 level).
- Proficiency in Microsoft Office, especially Excel.
- Accuracy, methodical approach, and results orientation.
- Strong interpersonal skills and ability to work in multicultural teams.
- Willingness to learn and collaborate.
Availability for short international business trips (2–3 days per quarter) is required.
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.
“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:
Our Enovis Purpose, Values and Behaviors on Vimeo
We offer a comprehensive benefits package which includes:
- Medical, Life, and Accidental Insurance
- Leaves and Holidays
EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
Skills Required
- Degree in Biology, Chemistry, Biomedical Engineering, or a related scientific discipline
- At least 1–2 years of Regulatory Affairs experience in the medical device industry
- Knowledge of EU MDR and major international medical device regulations
- Excellent command of Italian and English at B2/C1 level
- Proficiency in Microsoft Office, especially Excel
- Good time and priority management skills
- Accuracy, methodical approach, and results orientation
- Strong interpersonal skills and ability to work in multicultural teams
- Willingness to learn and collaborate
- Availability for short business trips to Switzerland, 2–3 days per quarter
Enovis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Enovis and has not been reviewed or approved by Enovis.
-
Healthcare Strength — Healthcare coverage is positioned as comprehensive, with multiple medical, dental, and vision plan options plus HSA/FSA accounts. Income protection offerings are also described as robust, including life, AD&D, and short- and long-term disability coverage.
-
Retirement Support — Retirement benefits include access to a 401(k) plan with an employer match described as competitive. This adds to the overall total-rewards value even where cash compensation sentiment is uneven.
-
Leave & Time Off Breadth — Time-off provisions are described as ample, including vacation, sick leave, and holidays. Paid parental and family leave is also offered, with a stated maximum of six weeks for eligible employees after birth or adoption.
Enovis Insights
What We Do
We are a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.
