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EU Manager: Quality Assurance / Regulatory Affairs

Impulse Dynamics
Frankfurt am Main
Vollzeit
15.11.2024
Vollzeit
Impulse Dynamics

EU Manager: Quality Assurance / Regulatory Affairs

Stellenbeschreibung

EU Manager: Quality Assurance / Regulatory Affairs
Frankfurt, Germany
Hope is Here!
Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company’s Optimizer® Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; and Uruguay.
How You’ll Add Value
The QA/RA EU Manager is responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements.
  • Responsible for serving as the PRRC for Impulse Dynamics, Inc. USA and the EC Representative
  • Responsible for oversight and execution of logistics.
Quality
  • Assist in the development and authoring of quality system policy, procedures, and instructions.
  • Assist Director, Quality Assurance with management of multiple Quality Management System functions.
  • Oversees the day-to-day operations of the Quality Management System in EU-
  • REP/Importer/Distributor of Impulse Dynamics, Inc. USA.
  • Audits and collaborates with outsourced processes in the EU/International to ensure quality control of incoming product and outgoing shipments (inspection, labeling, inventory tracking)
  • Manages the preparation and assists with the execution of external and internal audits.
  • Oversee EU/International complaints to ensure proper completion of EU field complaints, complete complaint investigations and report adverse events to regulatory to ensure timely reporting to regulatory authorities.
  • Performs investigations of EU related non-conformances, customer complaints and corrective actions
  • Ensures the timely and effective follow up of all identified or assigned quality issue
  • Manages the activities for device safety testing
  • Liaison for Clinical Affairs with regards to Quality compliance information
  • Authorized representative for Radiation Protection (§69 StrlschG) Safety Officer (§30, MPG2)
  • Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR Part 820, 21 CFR Part 812, MDSAP and MDR
Training
  • Provides new employees training at the EU location (Welcome/Quality Training)
  • Provides field personnel training on regulatory and/or QA issues
Regulatory
  • Maintains/checks the regulatory status of countries
  • Assists in the application for Registration Documents
  • Checks for Import Licenses of customers
  • Applies for Free Sales Certificates
  • Responsible for documents stamped/legalized at the Chamber of Commerce/local court
  • Assists in the negotiation of quality agreements when required
  • Assists with local special features (Waste Management with Italy, GTIN database for Dubai/UAE, EUDAMED) § Contact for the Regional Board § Contact for BfArM (Federal Institute for Drugs and Medical Devices) and DIMDI (German Institute of Medical Documentation and Information)
  • Follow requirements outlined in the EU Authorized Representative (EUAR)/Importer/Distributor agreement with Impulse Dynamics corporate in the U.S.
  • Designated Person Responsible for Regulatory Compliance per the MDR 2017/745.
Logistics
  • Shipment of product to the field
  • Processing returns to the US § Patient replacement devices
  • Shipment of marketing materials upon request. § Ordering boxes for shipping
  • ERP Transactions for device movement for the QA/RA/Logistics position
  • Customs clearance submissions for international shipments
  • Inventory control
What You’re Bringing with You
  • Well-developed written and verbal communication skills.
  • Strong interpersonal skills and ability to work in a team environment.
  • Ability to take initiative
  • Ability to maintain confidentiality.
  • Superior organizational skills and ability to maintain deadlines.
  • BS in Engineering or Life Science Field required.
  • 5-10 years of QA/RA experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP)
  • Trained ISO 13485:2016 auditor preferred.
  • Knowledge of European Medical Device Regulations and ISO Standards
  • Proficient in German and English
Our commitment to you
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.