Regulatory Affairs Manager (Medical Devices)

We are an innovative medical device start-up focused on cardiac surgery, developing a novel vein harvesting system to improve outcomes in coronary artery bypass grafting procedures. Having successfully completed proof-of-concepts, we are now in the critical phase of finalizing our product design, preparing for certification, and transferring the design to manufacturing. Located in the west of Vienna with excellent access to public transport via the U4 line, we offer a dynamic and collaborative work environment where cutting-edge technology and life-saving solutions come together. Join us in shaping the future of cardiac surgery and making a real impact on patients’ lives.

Regulatory Affairs Manager (Medical Devices)

Full-time position in Vienna (m/f/d)

Role Overview

As the Regulatory Affairs Manager, you will be the key driver of our regulatory strategy, ensuring our vein harvesting system meets all global regulatory requirements for CE marking, FDA clearance, and other certifications. You will lead the preparation and submission of regulatory documentation and work closely with authorities and notified bodies to bring our product to market. Your role will ensure that the development and commercialization processes comply with the necessary medical device regulations globally.

Key Responsibilities

• Lead the preparation, submission, and maintenance of regulatory filings, including technical files, design dossiers, and 510(k) submissions.
• Act as the primary contact for regulatory authorities, notified bodies, and competent authorities during the submission and approval process.
• Ensure all product development activities comply with applicable global regulations, including EU MDR, FDA 21 CFR 820, and relevant international standards.
• Keep up-to-date with global regulatory changes and assess their impact on the product and business strategy.
• Collaborate with cross-functional teams (R&D, QA, etc.) to ensure alignment with regulatory requirements throughout the product lifecycle.
• Review and approve labelling, promotional materials, and product documentation to ensure regulatory compliance.
• Oversee post-market regulatory compliance, including handling any changes, renewals, or vigilance reporting requirements.
• Provide regulatory guidance to the team on best practices, regulatory trends, and risk assessments.

Qualifications

• Bachelors degree in a relevant field; advanced degrees or professional certifications in Regulatory Affairs (e.g., RAC) are highly desirable.
• At least 5 years of experience in regulatory affairs within the medical device industry.
• In-depth knowledge of EU MDR, FDA regulations, and international medical device regulations.
• Proven experience in obtaining CE marking and FDA clearance, including familiarity with 510(k) or equivalent regulatory pathways.
• Strong communication skills with the ability to interact effectively with regulatory bodies and internal teams.
• Fluency in English is essential.
• Strong attention to detail, organizational skills, and ability to manage multiple regulatory projects simultaneously.
• Ability to work autonomously in a fast-paced, start-up environment.

What We Offer

• Competitive salary and benefits package.
• Flexible working hours and flexible remote work options to support work-life balance.
• Professional development opportunities and the chance to grow with the company.
• Convenient office location with excellent public transport connections (U4 line).
• The opportunity to work on life-saving technology in a high-impact role within a fast-growing start-up.
• A dynamic and collaborative environment where innovation and teamwork drive success.
• A supportive team culture with regular team events, fostering a strong sense of community.

How to Apply

If you are excited by the challenge of regulatory affairs and want to help shape the future of cardiac surgery with a breakthrough technology, we would love to hear from you! Please send your CV and a cover letter to [email protected].

We have set a minimum gross salary of EUR4,000 per month for this position. However, we are open to offering higher compensation based on your qualifications and experience.

Valeriot FlexCo
Dipl.-Ing. Dipl.-Ing. Michael Flatscher
[email protected]
Elßlergasse 26/8
1130 Wien
Web: http://www.valeriot.com