Regulatory Market Access Specialist
Regulatory Market Access Specialist
Enovis
Job description
Looking to build a career in device regulatory affairs and market access? Consider this Regulatory Market Access Specialist role at Enovis in Hyderabad.
Company Description
Enovis is an innovation driven medical technology company focused on developing solutions that improve outcomes and transform workflows. The company operates across orthopedics and beyond powered by improvement, global talent and innovation. Enovis brings together a range of products, services and integrated technologies to support active lifestyles worldwide. The company continues working to create outcomes for patients, teams and shareholders alike.
Job Summary
This role sits within Enovis Market Access team, based in Hyderabad. As a Regulatory Market Access Specialist you will support product approvals and renewals for medical devices in international markets. Prepare submissions manage product registrations and ensure ongoing compliance with global standards. The role also involves working with cross functional teams to resolve regulatory questions and product related issues.
Key Responsibilities
Process documentation for new and modified medical device introductions.
Act as a core team member on sustaining product development projects.
Resolve technical issues raised by international regulatory agencies.
Prepare documentation for regulatory registrations and licenses.
Define requirements needed for product approval in assigned countries.
Manage the release and shipment of products under controls.
Recommend ways to resolve barriers and internal disagreements.
Support the Market Access Lead with planning activities.
Approve design or manufacturing changes for existing products.
Send notifications to license and registration holders in international markets.
Maintain documentation to stay ready for external audits.
Provide guidance and regulatory training to cross functional teams.
Review product and advertising materials for regulatory compliance.
Monitor regulatory requirements and share their impact with relevant teams.
Maintain procedures that support compliance and business goals.
Stay updated on government regulations and industry guidance.
Support regulatory projects and requests as needed.
Educational Qualification
Bachelors degree, along with a minimum of 2 years of medical device industry experience in a role.
Skills Required
Prior experience with submissions for medical devices in European and international markets.
General understanding of product development processes and design controls.
Ability to manage projects at the same time.
Strong interpersonal and influencing skills.
Ability to manage projects independently and prioritize time effectively.
Written and spoken English communication skills.
Salary Structure
The average salary for a Regulatory Market Access Specialist role at Enovis is ₹6.5 Lakhs. ₹7.2 Lakhs per year.
Career Development
This role offers exposure to global regulatory and market access work within a growing medical technology company. Enovis also supports long term growth through a benefits package and opportunities to build deeper expertise across international regulatory markets.
How to Apply
Visit our job portal and search for the Regulatory Market Access Specialist role - Enovis.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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