Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d)

Description

Job Overview

• Role: Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d)
• Company: ONCARE GmbH
• Location: Munich
• Employment Type: Full-Time
• Category / Department: Quality Management
• Salary: Competitive / Not Disclosed — confirm during interview
• Key Skills / Technologies: Quality Management
• Listing Source: Arbeitnow

Job Description

At myoncare, we don’t just develop software – we are building an international health ecosystem that redefines care. Our platform connects patients, clinics, doctors, and partners within a single, intelligent system, creating something unprecedented: continuous, secure, and personalized care around the clock.

As part of our Quality & Regulatory Affairs team, you ensure that our innovation stands on a strong foundation of quality and compliance. You turn regulatory requirements into clear, practical standards and actively help shape and improve our quality management system across the organization, making a real impact on the safety and reliability of our products.

Tasks

• Perform gap analyses of regulatory documents and QMS documentation, derive and implement required adaptations in documentation and processes
• Keep regulatory documentation such as laws, standards, regulations and guidance documents up-to-date and ensure continuous compliance of QMS and product to these requirements
• Identify and execute regulatory pathways for successful market access
• Actively promote improvement in QMS processes
• Administration and maintenance of the QMS documentation
• Advise other departments in daily regulatory and quality-related activities
• Plan and perform employee trainings

Requirements

• At least three years of experience in Regulatory Affairs or Quality Department for medical devices, ideally of medical device software
• At least two years of experience in managing QM systems covering ISO 13485
• In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820 and relevant sections of the FD&C Act
• Experience in generating and adapting SOPs and Working Instructions together with respective departments such as Research & Development and Product Management
• Experience in Regulatory Affairs in USA markets beneficial
• Experience in medical device vigilance beneficial
• Knowledge of ISO 14971, EN 62304 and EN 62366 beneficial
• Independent working and a strong sense of responsibility for your own actions
• Drive to identify potential for improvement and to find solutions for stakeholders
• Thoroughness in everything you do, a great attention to detail and the ability to quickly adapt to new problems even on tight schedules
• Excellent time management and organizational skills
• Effective communication in international and interdisciplinary teams and active listening skills
• Excellent English proficiency (written and spoken), German proficiency is beneficial

Benefits

• Competitive salary with performance-based growth
• Central located office with plenty of lunch options
• Global team shaping the future of healthcare
• Coffee and tea stations for daily recharge
• Employee discounts
• Flat hierarchies with direct contact to decision-makers

Contribute to the digitalization of healthcare and take visionary step into the future with us!

Become part of the ONCARE family and apply today with your complete application documents, stating your earliest possible starting date and your salary expectations.

We are looking forward to hearing from you!

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Find more English Speaking Jobs in Germany on Arbeitnow

Salary & Compensation

The salary for this position has not been publicly disclosed. Compensation is typically determined based on your experience, skills, and interview performance. Use your research on industry benchmarks and the cost of living in the role's location to negotiate effectively.

In addition to base salary, many employers in this sector offer a comprehensive benefits package that may include:

• Annual or performance-based bonuses
• Health, dental, and vision insurance
• Provident Fund (PF) and Gratuity contributions (India)
• Paid Time Off (PTO), sick leave, and public holidays
• Professional development budget and learning allowances
• Stock options or Employee Stock Ownership Plans (ESOPs) at select companies
• Flexible or remote working allowances
• Parental leave and family health coverage

Note: The specific benefits offered by this employer should be confirmed during the offer stage. Not all benefits listed above may apply to every organisation or role type.

Work Arrangement

Type: On-Site / Full-Time

This is an on-site, full-time position. You will be expected to report to the office or designated work location during standard business hours, Monday through Friday. Some companies offer flexible start and end times or occasional work-from-home days at the manager's discretion. The company fosters a collaborative environment with open workspaces, dedicated meeting rooms, and structured team events.

Typical Interview Process

While each organisation structures its hiring differently, candidates for this type of role typically go through the following stages:

1. Resume and application screening
2. Introductory phone or video call with HR
3. Role-specific skill or competency interview
4. Final interview with the hiring manager or panel
5. Reference checks and offer discussion

Tip: Research the company's products, culture, and recent news thoroughly before each interview round.

About the Employer

ONCARE GmbH is the organisation posting this opportunity. While full company details are available on the original job listing, here is what you should research before applying:

• Company size and culture: Review the company's LinkedIn profile, Glassdoor reviews, and their official website to understand team size, work culture, and employee satisfaction.
• Products and services: Familiarise yourself with what the company builds, sells, or delivers. Being knowledgeable about their offerings will set you apart during interviews.
• Recent news: Search for any recent fundraising, acquisitions, product launches, or leadership changes — these often come up in interviews and signal company health.
• Location and offices: The role is based in or around Munich. Confirm office address, remote policy details, and travel requirements during the process.
• Where this listing was found: This job was sourced from Arbeitnow.

How to Apply & Preparation Tips

To apply for the Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d) position, follow these steps:

1. Tailor your resume: Customise your CV to match the specific requirements listed in the job description. Use keywords from the posting to pass Applicant Tracking System (ATS) filters.
2. Write a compelling cover letter: Even if not mandatory, a concise cover letter demonstrating your enthusiasm and fit for the role significantly improves your chances.
3. Apply via the original listing: Use the apply link on the original job post to submit your application. Avoid applying through third-party channels that may delay or lose your submission.
4. Prepare for phone screening: Be ready for an initial call within 3–7 business days of applying. Have your resume and a quiet space ready.
5. Follow up professionally: If you haven't heard back in 7–10 business days, a brief, polite follow-up email to the recruiter is acceptable and often appreciated.

Key skills relevant to this role include: Quality Management. Ensure these are prominently featured on your resume and LinkedIn profile.

Disclaimer: This listing is aggregated from a public job board for informational purposes. JobSetuu does not guarantee the accuracy or current availability of this position. Always verify the details on the employer's official careers page before applying.