Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

Medical Device Directive Regulatory Compliance Regulatory Compliance Global Project Management Regulatory Compliance Device Management ISO 13485 Standard ISO 13485 Standard Lifecycle Management Health Administration +6 more

Other Skills

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Strategic Planning
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Quality Assurance
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Collaboration
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Communication
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Leadership
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Teamwork
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Social Skills
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Innovation

Roles & Responsibilities

University degree in a scientific discipline (technical or life sciences preferred).
Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products.
In-depth knowledge of global medical device regulations, particularly EU MDR; familiarity with ISO 13485 and ISO 14155; knowledge of US FDA regulation is a plus.
Proven experience in global regulatory strategy and preparation of regulatory documentation for EU activities (clinical investigations, Notified Body opinions, CE certifications); strong track record in regulatory audits/inspections.

Requirements:

Develop regulatory strategies and technical documentation for 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 documentation preparation and meeting coordination.
Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization.

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About the Role

We are 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.