Enovis is hiring a Regulatory Market Access Specialist for its medical technology operations in Hyderabad, Telangana. This is a full-time regulatory affairs opportunity for professionals with experience in the medical device industry, regulatory submissions, international registrations, and market access activities.
The role involves supporting new product introductions, product modifications, regulatory approvals and renewals, international registrations, regulatory compliance, labeling reviews, and ongoing maintenance of medical device approvals.
Enovis Regulatory Market Access Specialist – Job Details
| Details | Information |
|---|---|
| Company | Enovis |
| Job Title | Regulatory Market Access Specialist |
| Job Type | Full Time |
| Location | Hyderabad, Telangana, India |
| Requisition ID | R0033326 |
| Experience | Minimum 2 years of medical device industry experience |
| Qualification | Bachelor’s degree |
| Industry | Medical Devices / MedTech |
| Work Area | Regulatory Affairs / Market Access |
About the Regulatory Market Access Specialist Role
The Regulatory Market Access Specialist at Enovis will work with the market access team to support the commercialization and ongoing regulatory compliance of new and modified medical devices.
The position involves hands-on regulatory affairs support, including preparing regulatory submissions, developing regulatory requirements, managing product registrations and renewals, responding to regulatory questions, and maintaining regulatory documentation.
The specialist will also collaborate with cross-functional teams involved in product development, manufacturing, regulatory planning, and sustaining activities.
Key Responsibilities
The selected candidate will be responsible for:
- Preparing and processing documentation for new product introductions and modified products in international markets.
- Supporting regulatory submissions, registrations, licenses, and approvals.
- Participating as a regulatory core team member in new product development and sustaining projects.
- Providing regulatory feedback throughout the product development lifecycle.
- Working with market access and cross-functional teams to resolve regulatory and technical issues.
- Defining regulatory requirements for medical devices in assigned countries.
- Managing the release and shipment of products subject to regulatory controls.
- Supporting the Market Access Lead with regulatory planning.
- Reviewing design and manufacturing changes for existing products.
- Ensuring applicable regulatory notifications are communicated to license and registration holders.
- Maintaining regulatory documentation for audits and submission packages.
- Reviewing device labeling and advertising materials for regulatory compliance.
- Monitoring changes in regulatory requirements and advising cross-functional teams about their impact.
- Providing regulatory training and technical guidance to internal teams.
- Developing and maintaining procedures that support regulatory compliance and business objectives.
- Supporting additional regulatory projects and requests as required.
Enovis Regulatory Affairs Specialist – Eligibility
Candidates applying for the Enovis Regulatory Market Access Specialist job should have:
- A Bachelor’s degree.
- At least 2 years of medical device industry experience as a Regulatory Specialist.
- Experience with regulatory submissions for medical devices.
- Exposure to European and international medical device markets.
- General understanding of product development processes and design controls.
- Ability to manage multiple projects simultaneously.
- Strong interpersonal and influencing skills.
- Ability to independently manage projects and prioritize work.
- Strong written and verbal English communication skills.
Key Skills
Relevant skills for this medical device regulatory affairs job include:
- Regulatory Affairs
- Market Access
- Medical Device Regulations
- Regulatory Submissions
- International Registrations
- Product Development
- Design Controls
- Regulatory Compliance
- Labeling Review
- Regulatory Change Management
- Cross-functional Collaboration
- Project Management
Benefits at Enovis
According to the provided job description, Enovis offers a benefits package that includes:
- Medical insurance
- Life insurance
- Accidental insurance
- Leaves and holidays
Benefits can be subject to applicable company policies and employment terms.
About Enovis
Enovis Corporation is a medical technology company focused on developing clinically differentiated solutions intended to improve patient outcomes and transform healthcare workflows. Its portfolio and operations span orthopedics and related areas of medical technology.
Enovis describes its purpose as “Creating better together”, with an emphasis on collaboration, innovation, continuous improvement, and patient outcomes.
How to Apply
