Director Quality and Regulatory Affairs, worldwide (m/f)

We are a midsize medtech manufacturer in the field of interventional cardiology and electrophysiology equipment with offices in Heilbronn, Germany and Maastricht, the Netherlands. For our main office in Heilbronn we are searching for a

Director Quality and Regulatory Affairs, worldwide (m/f)

The Q&R director establishes strategic goals in quality and regulatory affairs by gathering quality, business, service, and operations information; identifying and evaluating trends and options, and defining the course of action towards desired outcomes.

He/she defines procedures that maximize quality and regulatory standards; directing development and manufacturing sites on quality and regulatory testing (incoming, in process and final release), including risk analysis and testing of products in development as well as testing of finished goods, and goods in process.

- Develops strategies and implement programs to assure regulatory
compliance and standards of quality and regulatory. Provides leadership in responding to regulatory agencies (including FDA). Manages GMP compliance audit programs. Executes control over the following systems: change control, documentation control, product complaint investigation and analysis.

- External interaction includes customer audits, quality and regulatory agreements, identifying product quality and regulatory trends; recommending corrective actions, initiating and directing local market approvals with partners or 3rd party agencies.

- Provide leadership and guidance on design for quality and regulatory to new product development staff. Activities typically include reviewing designs/plans of proposed new products;

- Reviews procedures of departments by recommending solutions to problems or changes in procedures.

- Maintains professional and technical knowledge by attending educational workshops reviewing professional publications; establishing personal networks and benchmarking of state-of-the-art practices.

- Initiate and support workshops / events to continuously improve standard work and performance.

- Oversight over company policy and system for notifiable events (vigilance system, MDR) globally.

Candidate Profile:
- Master degree in engineering or similar discipline.
- Hands-on mentality with pragmatic attitude, approachable and
- Knowledge of ISO13485, 21 CFR 820 regulatory requirements.
- Minimum 8 years experience in Quality Management systems.
- Significant experience with notified bodies, audit procedures and
problem solving.
- Ability to collaborate and communicate cross-culturally and
- Ability to work effectively in a quickly changing, demanding
- Demonstrated leadership skills.
- Willing to work in a small team (1 DR, 1-2 external consultants)
- Willing to travel, including outside normal working hours
(approx. 20%).

We offer:
- Interesting and varied tasks in a committed and competent team
- Permanent full-time position in an attractive working environment
with flexible working arrangements
- Employer-funded pension

Would you like to join our enthusiastic team?
We are looking forward to receiving your comprehensive application including your desired salary and your availability either via e-mail to: or by mail to Schwarzer Cardiotek GmbH, Human Resources, Im Zukunftspark 3, D-74076 Heilbronn.

For any queries please do not hesitate to contact Mr. Wilfried Neubert, +49 7131 / 2774 500.
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