Global Regulatory Lead: Medical Devices & Comb. Products

Parexel International; Milano; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Parexel International is seeking an experienced Regulatory Affairs professional to lead regulatory strategy for medical devices and combination products across Europe. You will guide clinical investigations, CE markings, and interactions with health authorities, advising global project teams throughout development and authorization processes.

We value deep EU MDR knowledge, strong communication skills, and a proven track record in audits and regulatory submissions.

Competenze

• Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combinations.
• In-depth knowledge of global medical device regulations, especially EU MDR.
• Experience preparing Notified Body opinions and CE certifications.

Mansioni

• Develop regulatory strategies and technical documentation for medical devices and combination products.
• Represent regulatory affairs in global project teams and governance meetings.
• Lead regulatory interactions with health authorities and Notified Bodies.
• Manage regulatory activities across device development lifecycle and marketing authorization.
• Maintain global regulatory databases and ensure current information.

Conoscenze

Regulatory leadership

EU MDR knowledge

Global regulatory strategy

Clinical investigations

Communication skills

Fluent English

Formazione

University degree in a life science/technical field

Descrizione del lavoro

Parexel International is seeking an experienced Regulatory Affairs professional to lead regulatory strategy for medical devices and combination products across Europe. You will guide clinical investigations, CE markings, and interactions with health authorities, advising global project teams throughout development and authorization processes.

We value deep EU MDR knowledge, strong communication skills, and a proven track record in audits and regulatory submissions.