Regulatory Market Access Specialist

enovis; Hyderabad; Sur place; INR 700 000 - 1 100 000; Plein temps

Résumé du poste

Enovis seeks a Regulatory Market Access Specialist to bring new and modified medical devices to market and maintain ongoing compliance across international markets. The role involves hands-on regulatory submissions, cross-functional collaboration, and continuous improvement in regulatory practices.

You will support regulatory planning, ensure design and manufacturing changes meet regulatory standards, and contribute to global market access strategies with independence and analytical rigor.

Qualifications

• Bachelor's degree with a minimum of 2 years of medical device industry experience as a Regulatory Specialist.
• General understanding of the product development process and design controls.
• Ability to manage several projects simultaneously.
• Excellent command of English (spoken and written).

Responsabilités

• Handles preparation and processing of documentation for new product introductions and modified products in international markets.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance.
• Works with market access team and cross-functional peers to resolve regulatory/technical questions from agencies in international markets.
• Prepare documentation for international regulatory registrations and licenses.
• Define regulatory requirements necessary for regulatory approval of surgical devices for countries under responsibility.
• Manages release and shipment of products under regulatory controls to all regions.
• Reviews and approves design changes for existing products and notifies license/registration holders as needed.
• Maintains regulatory documentation for external audits and submission packages.
• Provides regulatory training to cross-functional teams.
• Reviews labeling and advertising for regulatory compliance.

Formation

Bachelor's degree in a relevant field

Description du poste

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 .

Job Title:

Regulatory Market Access Specialist

Role Summary :

The Regulatory Market Access Specialist will work in the market access team to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Market Access Specialist provides hands‑on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and preparation of submissions. The Regulatory Market Access Specialist performs regulatory submission/approval activities for specific Enovis products. The Regulatory Market Access Specialist ensures compliance with required regulations and established corporate standards. The Regulatory Market Access Specialist ensures that product approvals are properly maintained, and product re‑registrations are properly managed. The Regulatory Market Access Specialist will exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.

Key Responsibilities

• Handles the preparation and processing of documentation required for new product introductions and modified products in international markets.
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
• Works with market access team and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies in international markets.
• Prepare documentation for international regulatory registrations and licenses
• Define regulatory requirements necessary for regulatory approval of Surgical for the countries under his/her responsability
• Manages the release and shipment of products under regulatory controls to all regions.
• Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
• Coordinates and assists the Market Access Lead with defining regulatory requirements in Regulatory planning process.
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations and sends applicable notifications to license and registration holders in international markets.
• Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages
• Provides technical guidance and regulatory training to cross‑functional teams.
• Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.
• Monitor the development of new regulatory requirements and advise of the impact to cross‑functional teams.
• Develops and maintains procedures to ensure compliance and support business goals.
• Maintains proficiency in government regulations and guidances.
• Support other regulatory requests or projects as needed.

Preferred Qualifications

• Bachelor's degree with a minimum of 2 years of medical device industry experience as a Regulatory Specialist
• Prior experience with regulatory submissions for medical devices in European and international markets
• General understanding of the product development process and design controls
• Ability to manage several projects simultaneously
• Strong interpersonal and influencing skills
• Ability to independently manage projects, prioritize time and communicate effectively
• Excellent command of English (spoken and written).

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 a