Regulatory Affairs Sustaining Specialist

Enovis; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Enovis seeks a Regulatory Affairs Sustaining Specialist to join the International Surgical division. You will manage technical documentation for MDR registrations and maintain medical device certifications, coordinating with product development, quality, clinical and manufacturing teams.

The role requires a scientific degree, 1–2 years in Regulatory Affairs, knowledge of MDR, and fluent Italian and English.

Qualifications

• Degree in scientific disciplines (Biology, Chemistry, Biomedical Engineering, or related).
• 1–2 years of experience in Regulatory Affairs within the medical device industry.
• Knowledge of MDR and major international regulations for medical devices.
• Excellent command of Italian and English (B2/C1).
• Proficiency in Microsoft Office, especially Excel.

Responsibilities

• Prepare, update, and manage technical docs for MDR registration and maintenance.
• Collaborate with product development, quality, clinical and manufacturing teams.
• Manage regulatory changes, including reportability assessments and inform authorities.
• Communicate with notified bodies and competent authorities.
• Analyze deficiency reports and prepare responses.
• Help define and improve internal regulatory processes.

Skills

Regulatory affairs

Time management

Interpersonal skills

Willingness to learn

Multicultural teamwork

Education

Science degree

Tools

Microsoft Office

Job description

Who We Are

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 Italian and 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 business trips to Switzerland (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.