Healthcare Regulatory Program Manager MDSAP/ISO 13485 (f/m/d)

TN Germany; Plattling; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Healthcare Regulatory Program Manager to join their dynamic team in Plattling. This role involves overseeing certification processes for medical devices, ensuring compliance with international regulations, and managing diverse projects. The ideal candidate will have extensive experience in management system certification and a deep understanding of medical device regulations. With opportunities for remote work and a focus on continuous improvement, this position offers a chance to make a significant impact in the healthcare sector while enjoying a supportive and innovative work environment.

Leistungen

Remote Work Options

Flexible Hours

Health and Fitness Programs

Bike Leasing

Pension Plan

Ongoing Training

Challenging Projects

Qualifikationen

• Degree in relevant fields or Engineering Technology with 5 years' experience.
• Over 5 years in management system certification for medical devices.

Aufgaben

• Oversee certification applications and compliance assessments.
• Train assessors and manage certification projects effectively.

Kenntnisse

Management System Certification

Regulatory Knowledge (MDSAP, EU MDR/IVDR, FDA)

Communication Skills

Conflict Resolution Skills

Technical Competence in QMS Assessment

Project Management

Proficiency in German and English

Ausbildung

Degree in Technical, Medical, or Scientific Fields

Engineering Technology/Associates Degree with 5 years' experience

Jobbeschreibung

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Healthcare Regulatory Program Manager MDSAP/ISO 13485 (f/m/d), Plattling

Client: CSA Group

Location: Plattling, Germany

Job Category: -

EU work permit required: Yes

Job Reference: edcc3c3d8b1b

Job Views: 1

Posted: 28.04.2025

Expiry Date: 12.06.2025

Job Description:

Employment Type: Permanent

Hours: Full-time

We need you to help form a world-class team. CSA Group's activities focus on making the world better, safer, and more sustainable. Since 1919, we've developed over 3,500 standards, codes, and related products. Headquartered in Canada, with over 30 labs and offices worldwide, we offer testing, inspection, and certification services to ensure products meet strict safety, performance, and environmental standards. Our employees take pride in making a positive impact on lives. Join us to continue this mission.

Job Summary:

CSA Group Europe seeks a Healthcare Regulatory Program Manager MDSAP/ISO 13485 to join our Healthcare Regulatory Services Team in Germany and across Europe. You will implement and maintain procedures for high-quality certification services, ensuring client needs are met efficiently and products are safe for public use.

Responsibilities include:

1. Oversee and review certification applications, audit planning, and assessments related to compliance with national and international regulations.
2. Ensure assessments address manufacturer responsibilities regarding product safety and performance.
3. Develop and improve assessment procedures in line with CSA Group and external standards.
4. Train assessors and conduct calibration events.
5. Demonstrate assessment effectiveness to authorities and ensure review compliance.
6. Evaluate technical and clinical staff.
7. Represent CSA at congresses and technical events.
8. Manage certification projects, ensuring safety compliance, timeliness, and budget adherence.
9. Assist clients with problem-solving confidentially.
10. Handle diverse, potentially high-revenue projects.
11. Consistently deliver projects on time and within budget.
12. Maintain productivity and quality standards.

Qualifications and Skills:

1. Degree in technical, medical, or scientific fields; or Engineering Technology/Associates Degree with 5 years' relevant experience.
2. Over 5 years in management system certification for medical devices, preferably with MDSAP recognition.
3. Deep knowledge of regulations and standards for medical devices and IVDs, including MDSAP, EU MDR/IVDR, FDA, etc.
4. Experience in evaluating and deciding on medical and IVD device conformity assessments.
5. Strong communication and conflict resolution skills.
6. Technical competence in QMS assessment under MDSAP.
7. Ability to manage multiple assessments and adapt to changing schedules.
8. Proficiency in German and English; other European languages advantageous.
9. Willingness to travel up to 15%.

What We Offer:

• Flat hierarchies and an intercultural environment.
• Remote work options and flexible hours.
• Challenging projects and opportunities for innovation.
• Health and fitness programs, Bike leasing, Pension plan, and other benefits.
• Ongoing training and permanent employment.