Chief of Regulatory Affairs & Quality (m/w/d)

About This Opportunity

We are representing a confidential medical device startup in its early development phase. Our client is developing next-generation cardiovascular implants for patients who cannot be treated with currently available standard solutions. This is a founding role at their second location in Magdeburg, where you will build the regulatory and quality function from the ground up.

The company holds a granted German patent with international filings underway, has characterized initial prototypes, and collaborates closely with university medical centers and established contract manufacturers. Ahead lies the path to first clinical use and regulatory approval of a Class III medical device, including preclinical testing and animal studies.

This is not a role where you maintain existing systems—you will decide how everything is structured from day one, working directly with the founders.

Responsibilities

• Develop the regulatory strategy for Europe and the USA, define the conformity assessment route and timeline for a Class III product, and manage selection and collaboration with the Notified Body
• Build the Quality Management System according to ISO 13485 from the ground up and lead it to certification
• Own risk management per ISO 14971 and plan biological evaluation according to ISO 10993
• Structure technical documentation, define applicable standards (including ISO 25539-1 and ISO 7198), and derive test plans for development and verification
• Plan the preclinical testing strategy from bench testing through biological evaluation to GLP-compliant animal studies, ensuring generated evidence meets regulatory authority requirements
• Prepare clinical evaluation and the planned First-in-Human study per ISO 14155, including interaction with authorities and ethics committees, FDA Pre-Submissions, and applications for Breakthrough programs
• Qualify contract manufacturers from a regulatory perspective, define requirements for process validation and supplier management, and anchor them contractually
• Build and lead your own team at the Magdeburg location over time

What We're Looking For

• Completed degree in medical technology, engineering, natural sciences, or comparable qualification
• Several years of experience in medical device development, ideally in the cardiovascular field—especially with Class III implantable products or similar technologies
• Deep knowledge of regulatory requirements under MDR and FDA, including approval pathways for high-risk products
• Hands-on experience building, operating, or auditing a QMS per ISO 13485, plus risk management per ISO 14971
• Drive to execute work yourself rather than delegate, with ability to set priorities in a small, resource-constrained team
• Excellent German and English communication skills, written and spoken
• Willingness to travel occasionally to the Hamburg location and to partner sites

How We Work with You

Candidates apply directly through Get A Job.ai. Our talent team will conduct an initial screening to understand your background and motivations. If there's a mutual fit, we will submit your profile to our client for consideration. Please do not contact the client directly—all communication flows through our recruiting process to protect confidentiality and ensure a structured evaluation.

When you apply, please skip the traditional cover letter and photo. Instead, share three bullet points: which regulatory project you've found most interesting so far, and why this opportunity appeals to you. Include your salary expectations as well.

Pay

Compensation details will be discussed during the screening process and are competitive with market and industry standards for this seniority level in Germany. The client offers flexibility to find a solution that fits your life situation.

Get A Job.ai is an equal opportunity recruiter. We welcome applications regardless of ethnic origin, gender, religion or belief, disability, age, or sexual identity.