Regulatory Affairs Specialist

TN Germany; Deutschland; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Regulatory Affairs Specialist to manage international product registrations and ensure compliance with regulations for medical devices. This role involves leading global registration efforts, collaborating with cross-functional teams, and maintaining relationships with Health Authorities. The ideal candidate will possess a strong background in regulatory affairs, with experience in Class I, II, and III medical devices, and a deep understanding of EU and US regulations. Join this innovative firm to contribute to impactful projects in the medical device sector, while advancing your career in a dynamic environment.

Qualifikationen

• Bachelor's degree in Life Sciences or Engineering required.
• Several years of experience in Regulatory Affairs essential.

Aufgaben

• Manage international product registration submissions and oversee regulatory activities.
• Collaborate with teams for regulatory guidance and support product launches.

Kenntnisse

Regulatory Affairs

Project Management

Problem Solving

Documentation Skills

Knowledge of EU Regulations

Adaptability

Ausbildung

Bachelor's degree in Life Sciences

Master's degree in Engineering

Tools

Quality Systems (QSR, ISO, GxP)

Jobbeschreibung

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Refined Job Description:

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• Manages and coordinates international product registration submissions, oversees internal regional regulatory activities, and ensures compliance with relevant regulations and standards.
• Leads regulatory efforts on global product registrations to meet business needs for product growth and geographical expansion.
• Engages with cross-functional teams to provide regulatory guidance, services, and capabilities supporting product launches and market expansion.
• Coordinates submissions and approvals of applications, ensuring accuracy and regional compliance.
• Plans and tracks product registration and renewal activities, managing expirations, renewals, and new applications in line with portfolio priorities.
• Manages relationships with Health Authorities to stay informed of requirements and expectations, sharing regulatory intelligence with colleagues.
• Participates in regulatory improvement projects.

Roles and Responsibilities

• Manage international product registration submissions and oversee regional regulatory activities.
• Lead global product registration efforts to support business growth and expansion.
• Collaborate with cross-functional teams for regulatory guidance and support product launches.
• Coordinate application submissions and approvals, ensuring regional appropriateness.
• Track registration and renewal activities, managing timelines and compliance.
• Maintain relationships with Health Authorities and share regulatory intelligence.
• Participate in regulatory process improvement initiatives.

Education and Experience

• Bachelor's degree or higher in Life Sciences, Engineering, or related fields.
• Several years of experience in Regulatory Affairs.
• Experience with Class I, II, and III medical devices.
• Deep understanding of laws, regulations, and guidelines for medical devices.
• Proven experience with international regulatory documentation and submissions, including STEDs, Design Dossiers, Technical Files, and registrations across various regions.
• Strong knowledge of EU (MDD/MDR) regulations and US regulatory submissions (IDE, 510(k), PMA).
• Familiarity with Quality Systems requirements like QSR, ISO, and GxP.
• Leadership and project management skills to handle complex projects and timelines.
• Ability to identify compliance risks and escalate appropriately.
• Stay updated with changing regulations and standards.
• Excellent computer skills, including document formatting and publishing.
• Strong problem-solving skills and adaptability to changing priorities.