Design Control Process Manager for R&D (Medical Devices) m/f/d

Novanta; Berlin; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading medical device firm in Berlin seeks a Quality R&D Manager to ensure compliance with regulatory standards in medical device development. The ideal candidate should possess a technical degree, several years in a regulated industry, and strong experience with ISO regulations. You will be responsible for defining processes and optimizing product development, and must be fluent in English with German proficiency required. Join us to drive innovation in minimally invasive medicine.

Qualifikationen

• Several years of experience in a highly regulated industry, preferably medical devices.
• Experience in product development or process management is beneficial.
• Strong understanding of ISO 13485, 21 CFR 820, EU-MDR, and ISO 14971.
• Experience in implementing Design Controls and risk management in development.
• Awareness of current regulatory developments and standards.
• Familiarity with documentation requirements and general regulatory submission processes.

Aufgaben

• Define, maintain and train R&D processes for medical devices in accordance with ISO 13485, 21 CFR 820, EU-MDR.
• Continuously adapt and optimize those processes within QMS.
• Act as the primary contact for R&D, Design Assurance, Regulatory Affairs, Product Management.
• Provide proactive guidance on quality and regulatory requirements during development.
• Ensure technical documentation is compliant with internal SOPs and external standards.
• Ensure regulatory compliance by collaboration with Regulatory Affairs.
• Structure and maintain Design History Files throughout the product development.
• Drive process optimization through continuous improvement.
• Support internal and external audits and inspections.

Kenntnisse

Analytical skills

Organizational skills

Project management

Excellent communication

Cross-functional collaboration

Fluent in English

German proficiency (minimum B2)

Proficient in MS Office

Experience with ERP/QMS systems (e.g., SAP)

Ausbildung

Technical or scientific degree

Qualification in quality management (e.g., certified auditor)

Tools

MS Office

ERP/QMS systems (e.g., SAP)

Jobbeschreibung

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission‑critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in the Americas, Europe and Asia‑Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

This position is part of Novanta’s World of Medicine (WOM) business unit, which specializes in minimally invasive medicine. WOM develops and manufactures devices and accessories that enable surgeons to operate through small incisions. Our portfolio includes cameras, insufflators, medical pumps, and tubing systems that simplify diagnosis and treatment. Our teams collaborate with physicians and technical experts to continuously drive innovation in minimally invasive surgery.

Position Summary

The position is responsible for establishing and maintaining R&D related processes within quality management system (QMS) in compliance with ISO 13485, 21 CFR 820, and EU‑MDR, with a focus on Design Control, Design Change, Risk Management and Design Transfer. The role drives optimization of product development processes to ensure that new medical devices are developed efficiently, safely, and in compliance with regulatory requirements and legacy devices are maintained to the applicable regulations. The role requires close collaboration with Design Assurance, Regulatory Affairs, R&D, Quality Assurance, Quality Management and other stakeholders.

Key Responsibilities

• Define, maintain and train R&D processes for medical devices in accordance with ISO 13485, 21 CFR 820, EU‑MDR, and other applicable standards.
• Continuously adapt and optimize those processes within QMS in cooperation with R&D to evolving regulatory requirements and internal standards.

Further Tasks and Responsibilities

• Act as the primary contact for R&D, Design Assurance, Regulatory Affairs, Product Management and further stakeholders for R&D and Design Control topics in alignment with QM team.
• Provide proactive guidance on quality and regulatory requirements during development.
• Ensure technical documentation is compliant with internal SOPs and external standards, via good documentation practice, guidance documents and continuous training to facilitate documentation creation and international submissions.
• Ensure regulatory compliance by collaboration with Regulatory Affairs to embed regulatory requirements into development processes that ensure traceability from product requirements through design outputs to verification and validation.
• Structure and maintenance support of compliant Design History Files (DHF) throughout the product development.
• Active contribution to innovation processes by integrating quality and regulatory perspectives especially also considering AI.
• Initiate and participate in cross‑functional process harmonization and improvement initiatives.
• Drive process optimization, by continuous improvement, providing and analyzing metrics and driving improvement projects.
• Apply Lean Six Sigma and/or other Q‑methodologies to enhance development efficiency.
• Support internal and external audits and inspections, especially in development processes.

General Tasks

• Ensure strict compliance with quality, safety, and environmental regulations.

Your profile

• Technical or scientific degree, ideally with additional qualification in quality management (e.g., certified auditor).
• Several years of experience in a highly regulated industry, preferably medical devices.
• Experience in product development or process management is beneficial.
• Strong understanding of ISO 13485, 21 CFR 820, EU‑MDR, and ISO 14971.
• Experience in implementing Design Controls and risk management in development.
• Awareness of current regulatory developments and standards.
• Familiarity with documentation requirements and general regulatory submission processes.

Skills

• Strong analytical and organizational skills.
• Project and process management experience.
• Excellent communication and cross‑functional collaboration skills.
• Fluent in English; German proficiency (minimum B2) required.
• Proficient in MS Office and ERP/QMS systems (e.g., SAP).

Travel requirements

• Willingness to travel occasionally to other company sites and customer locations.