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Parexel Regulatory Affairs Consultant (Medical Device and Combination Product Expert) Recruitment 2026: Apply Online for 1 Vacancies | jobscheck.in

Parexel

Parexel Regulatory Affairs Consultant (Medical Device and Combination Product Expert) Recruitment 2026: Apply Online for 1 Vacancies

Regulatory Affairs Consultant (Medical Device and Combination Product Expert)

📍 Location: Milan, Italy

💼 Type: Private

💻 Work Mode: Remote/Office-based

Experience Required

5+ years

Salary / Package

null

Work Mode

Remote/Office-based

Openings

Job Overview

About the Role

Parexel is seeking an experienced Regulatory Affairs professional to lead medical devices and combination products regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and marketing authorizations, and serve as the key regulatory representative for our global project teams. The role can be home or office-based in various European locations.

Key Responsibilities

Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products.
Represent the regulatory affairs function in global project teams and governance meetings.
Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings.
Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization.
Maintain global regulatory databases with accurate and current information.
Collaborate with CMC and QA departments on device change control processes and global submission requirements.
Support internal and external audits related to medical device quality systems.
Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.

Skills and Experience

University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products.
In-depth knowledge of global medical device regulations, in particular EU MDR. Knowledge of US FDA regulation would be a plus.
Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, Notified Body opinions, CE certifications).
Familiarity with medical devices regulatory framework including EU-MDR, ISO 13485 and ISO 14155.
Experience also in vitro diagnostic devices would be a plus.
Strong track record representing companies during regulatory audits and inspections.
Excellent communication and interpersonal skills.
Fluent in English, written and spoken.
Proficiency with regulatory systems including Veeva and TrackWise would be a plus.

About Parexel

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Why Work at Parexel?

Patient-led approach: Inspired by patients, delivering first-time quality and on-time projects.
Supportive and inclusive environment: Thrive on collaboration, caring, and inclusivity.
Career growth opportunities: Challenging assignments, diverse product types, and global exposure.
Flexible work arrangements: Remote work options available.
Global exposure: Work with a global network of colleagues and clients.
Learn from experts: Mentorship from experienced regulatory professionals.

Fraud Alert

Please be aware of fraudulent activity by scammers impersonating Parexel employees. If you are concerned about a recruiter or offer, please notify Jobs@Parexel.com immediately. Always verify communications through official Parexel channels.

Key Job Details

Company Name	Parexel
Job Role	Regulatory Affairs Consultant (Medical Device and Combination Product Expert)
Experience	5+ years
Salary Range	null
Job Type	Private
Work Mode	Remote/Office-based
Openings	1
Job Location	Milan, Italy

Key Responsibilities

[“Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products.”, “Represent the regulatory affairs function in global project teams and governance meetings.”, “Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings.”, “Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization.”, “Maintain global regulatory databases with accurate and current information.”, “Collaborate with CMC and QA departments on device change control processes and global submission requirements.”, “Support internal and external audits related to medical device quality systems.”, “Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.”, “Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.”]

Requirements & Qualifications

[“University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.”, “Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products.”, “In-depth knowledge of global medical device regulations, in particular EU MDR. Knowledge of US FDA regulation would be a plus.”, “Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, Notified Body opinions, CE certifications).”, “Familiarity with medical devices regulatory framework including EU-MDR, ISO 13485 and ISO 14155.”, “Experience also in vitro diagnostic devices would be a plus.”, “Strong track record representing companies during regulatory audits and inspections.”, “Excellent communication and interpersonal skills.”, “Fluent in English, written and spoken.”, “Proficiency with regulatory systems including Veeva and TrackWise would be a plus.”]

Required Skills

[“Regulatory Strategy Development”, “Technical Documentation Preparation”, “EU MDR Expertise”, “US FDA Regulations (Plus)”, “ISO 13485”, “ISO 14155”, “Health Authority Interactions”, “Notified Body Opinions”, “CE Certification Processes”, “Audit and Inspection Representation”, “Cross-functional Collaboration”, “Communication Skills”, “Interpersonal Skills”, “Problem-Solving”, “Detail-Oriented”, “Veeva (Plus)”, “TrackWise (Plus)”]

About Parexel

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We do not charge any money for job alerts, scheduling, or application processes.
If a recruiter demands any payment or “security deposit” in exchange for a job offer, it is a scam.
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🚀 Apply Now via Official Portal

Frequently Asked Questions

Q: What is the primary focus of this Regulatory Affairs Consultant role?

A: The primary focus is to lead medical devices and combination products regulatory strategy, providing expert guidance on regulatory pathways for clinical investigations and marketing authorizations.

Q: What are the key responsibilities for this position?

A: Key responsibilities include developing regulatory strategies, preparing technical documentation, interacting with health authorities, managing regulatory activities, and maintaining databases.

Q: What is the minimum experience required for this role?

A: A minimum of 5+ years of experience in regulatory affairs for medical devices and drug-device combination products is required.

Q: What educational background is necessary?

A: A university degree in a scientific, technical, or life science discipline is required.

Q: What are the key regulatory frameworks mentioned?

A: In-depth knowledge of global medical device regulations, particularly EU MDR, is essential. Familiarity with US FDA regulations, ISO 13485, and ISO 14155 is also relevant.

Q: What is the work location and flexibility?

A: The role can be home or office-based in various European locations, offering flexibility.

Q: How can I apply for this position?

A: You can apply online through the Parexel careers portal using the provided application link.

Q: What should I do if I suspect fraudulent activity related to this job posting?

A: If you are concerned about fraudulent activity, please notify Jobs@Parexel.com immediately. Always verify communications through official Parexel channels.

Disclaimer: This job post is prepared by collecting data from the official career page of Parexel. We are not direct recruiters or representatives. Candidates should carefully review the requirements and policies on the company’s portal before initiating an application.