Regulatory Affairs Manager - Class II (m/f/d)

TN Germany; Obergurig; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a forward-thinking company as a Regulatory Affairs Manager and play a crucial role in ensuring compliance for innovative medical devices. In this dynamic position, you will research regulatory frameworks, guide product development, and support market access strategies. Collaborate with a talented international team while managing exciting projects that impact the healthcare industry. If you have a passion for regulatory affairs and a strong background in medical devices, this is the perfect opportunity to make a significant impact in a rapidly evolving field.

Leistungen

Exciting international projects

Dynamic environment with local and international talents

Qualifikationen

• 5+ years in Regulatory Affairs for medical devices.
• In-depth knowledge of US and Canada regulations.
• Regulatory certifications like RAC are an asset.

Aufgaben

• Research and determine regulatory requirements for submissions.
• Evaluate preclinical and clinical documents for regulatory filing.
• Provide regulatory input for inspections and audits.

Kenntnisse

Regulatory Affairs

Compliance Activities

Product Development

Quality Management Systems

Collaboration Skills

Communication Skills

Ausbildung

Master’s degree in science

Tools

ISO 13485

ISO 14971

Jobbeschreibung

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Regulatory Affairs Manager - Class II (m/f/d), Obergurig

Client: ontex

Location: Obergurig, Germany

Job Category: Other

EU work permit required: Yes

Job Reference: 3bbeedf77055

Job Views: 1

Posted: 09.05.2025

Expiry Date: 23.06.2025

Job Description:

Date: May 7, 2025

Employment Schedule: Location: Aalst, BE, 9320 Grosspostwitz, DE, 2692

Regulatory Affairs Manager - Class II (m/f/d)

Ontex is a leading international provider of disposable personal hygiene solutions for all generations. With a global team of around 7,500 employees, we develop, produce, and distribute in about 100 countries through leading retailers and healthcare providers. Ontex was founded in Belgium in 1979 and is listed on Euronext Brussels.

To reinforce our Quality team, we are looking for a Regulatory Affairs Manager - Class II (m/f/d).

Responsibilities:

1. Regulatory Frameworks and Strategy: Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways, and compliance activities. Monitors and evaluates the regulatory environment and provides internal advice throughout the product lifecycle to ensure product compliance. Identifies the need for new regulatory procedures and SOPs, and participates in their development and implementation. Helps train stakeholders on current and new regulatory requirements. Identifies requirements and obstacles for market access and distribution, and assists in developing regulatory strategies.
2. Product Development and Registration: Evaluates proposed preclinical, clinical, and manufacturing documents for regulatory filing and offers plans/strategies for changes. Assembles and maintains regulatory files to support submissions. Advises stakeholders on regulatory requirements. Monitors the review process with regulatory authorities and communicates with them during submissions.
3. Post-approval/Postmarket: Provides regulatory input and support for inspections and audits. Submits changes and updates product information. Ensures compliance with licenses, registrations, and postmarket requirements.

Profile:

• Master’s degree in science or equivalent experience
• Minimum of 5 years in Regulatory Affairs for medical devices
• In-depth knowledge of US and Canada regulations, standards, and guidance for medical devices
• Knowledge of regulations in other regions is an asset
• Knowledge of quality management systems and standards such as ISO 13485, ISO 14971
• Regulatory certifications like RAC are an asset
• Interest or experience in Software as Medical Device (SAMD)
• Fluent in English; German is preferred
• Strong collaboration and communication skills

We offer:

• Exciting, international projects
• A dynamic environment with local and international talents