We are presently looking for a qualified quality professional who would be thrilled to join our Quality Unit team based in our company headquarter at Berlin. The successful applicant must be motivated, goal oriented, structured and passionate to make a difference with the willingness to expand their knowledge horizons to deliver best in class quality to stakeholders. The role will report directly to the Vice President of Quality, Regulatory & Risk Management and will be responsible for the company headquarter and daughter affiliate companies under the organizational structure of MagForce AG.

MAIN TASKS

• Assist the QMS activities to ensure compliance with EN ISO 13485:2016, MDD 93/42/EEC and MDR 2017/745 at company headquarters.
• Assist in the integration of QM processes and product technical files from daughter affiliates, to the existing MagForce QMS SharePoint.
• Engage in the continual improvement discussions of existing QMS processes and creation of robust & lean QMS processes.
• Support all assigned process owners to create and maintain their SOPs, Work instructions & Forms in compliance with applicable standards and regulations.
• Perform the review of applicable norms, standards & guidelines and work together with process owners and product managers to ensure all new applicable requirements are covered.
• Prepare and support sites for audits and inspections. Liaise with notified bodies and internal audit contractors for audit planning.
• Perform supplier audits (as lead or co-) as per the supplier audit program.
• Quality Management contact to maintain Quality Agreements and Non-Disclosure Agreements with suppliers.
• Lead and moderate the NCR (Non-Conformance Report) committee meetings and CAPA review meetings together with different crossfunctional teams.
• Lead projects for UDI and ERP system implementation.
• Work with contract partners to ensure the language translations of applicable product technical files are available in order to support the Regulatory Team in their efforts of device registrations in target countries.

YOUR COMPETENCIES

• Minimum 3-5 years of professional experience by working in a Quality Management role with a medical device company.
• Working knowledge of EN ISO 13485:2016 and MDD 93/42/EEC.
• Knowledge of MDR 2017/745 is a plus.
• Working proficiency to use Microsoft Office 365 package tools (including Microsoft SharePoint).
• Working knowledge of root cause analysis tools like 5Whys, Fishbone Ishikawa, affinity diagram etc.
• Knowledge of 8-D, Kaizen, Value Stream Mapping, Lean Six-Sigma is a plus.
• Experience of organizing and performing Q&R audits.
• Excellent written and verbal command of German (minimum C1/C2) and English language.
• Position might require to travel domestic (10%) and International when required.

WE OFFER

• Good perks and benefits (including company pension scheme)
• Experience based competitive salary
• Performance based bonus

COMPANY

MagForce AG is a world leader in the field of nanotechnology-based tumor therapy, and the first company worldwide to receive European approval for therapeutic medical device containing nanoparticles. Our NanoTherm^® Therapy System of medical devices allows the targeted treatment of solid tumours through heat by means of superparamagnetic
nanoparticles.

For further information, you are most welcome to visit our
website www.magforce.de.

Have we picked your interest to join a future oriented employer involved in dealing with therapies related to the
new age cancer treatment?
Then feel free to forward your complete application with a CV and cover letter (also showing your latest entry date and desired compensation) to the following email id:sekretariat@magforce.com

We are presently looking for a qualified regulatory affairs professional who would be thrilled to join our Quality Unit team based in our company headquarter at Berlin. The successful applicant must be motivated, goal oriented, structured and passionate to make a difference with the willingness to expand their knowledge base. The role will report directly to the Regulatory Affairs Manager. The successful candidate will be responsible for the company headquarter and daughter affiliate companies under the organizational structure of MagForce AG.

MAIN TASKS

• Performing and monitoring of medical device registration with prime focus in the EU Market.
• Performing medical devices lifecycle management activities for devices of risk Class I-III from regulatory perspective.
• Creating and maintaining Technical Documentation for class I – III devices.
• Implementing and ensuring compliance with current regulatory requirements between cross functions.
• Performing gap analysis on any new applicable regulatory requirements.
• Coordinating communication between Regulatory Affairs and Development plus Product Management departments.
• Supporting Q&R - activities related to QMS requirements (e.g. review of design documents within the design control process)
• Coordinating Clinical evaluation activities would be an advantage.

YOUR COMPETENCIES

• 3-5 years of professional experience in a similar position in Regulatory Affairs.
• Bachelor/Master/PhD degree in natural sciences or engineering. Ideally with knowledge of tumor therapy, oncology.
• Working experience with MDD 93/42/EEC, EN ISO13485:2016, EN ISO14971.
• Very good knowledge of MDR 2017/745.
• Knowledge of MEDDEV 2.7/1 rev.4 would be an advantage.
• Excellent written & verbal command of German (minimum C1/C2) & English.
• Very good Microsoft Office skills.
• Analytical thinking, structured and independent way of working will round up the perfect candidate.

WE OFFER

• Good perks and benefits (including company pension scheme).
• Experience based competitive salary.
• Performance based bonus.

COMPANY

MagForce AG is a world leader in the field of nanotechnology-based tumor therapy, and the first company worldwide to receive European approval for therapeutic medical device containing nanoparticles. Our NanoTherm® therapy allows the targeted treatment of solid tumours through heat by means of superparamagnetic nanoparticles. Our medical devices include NanoTherm®, NanoPlan® and NanoActivator® and are approved for the treatment of brain tumours throughout the EU.

For further information, you are most welcome to visit our website www.magforce.de. 

Have we picked your interest to join a future oriented employer involved in dealing with therapies related to the new age cancer treatment?
Then feel free to forward your complete application with a CV and cover letter (also showing your latest entry date and desired compensation) to the following email id:
sekretariat@magforce.com.