Regulartory Affairs Device Manager (all genders)

Company Description

We are the designers of today for the world of tomorrow.

As one of the world's leading engineering service providers, we at ALTEN are committed to positively shaping the future of our partners, the careers of our employees and the challenges facing our society and environment.

More than 50,000 employees in 30 countries are already working on innovative solutions in various engineering and IT sectors such as automotive, aerospace, renewable energy, medical technology and railway technology.

Job Description

YOU…

• lead and manage registration projects for medical devices in compliance with relevant standards and regulations (such as Notified Body, EMA, FDA)
• collaborate closely with regulatory autorities to ensure adherence to all regulatory requirements
• prepare, review and submit technical documentation for international approvals.
• provide internal teams with regulatory expertise throughout the product lifecycle
• maintain and update regulatory databases and systems
• analyze and assess regulatory developments to inform necessary adjustments in the company's strategy
• participate in internal and external audits, ensuring compliance with quality standards
• support implementation of efficient processes and SOPs
• collaborative and proactive engagement in project and team initiatives

Qualifications

YOU…

• hold a university degree in natural sciences, ideally PhD, or equivalent qualifications
• have minimum 3 years of experience working in the field of Device Regulatory
• have strong communication skills and are actively reaching out
• are able to understand and connect across functions
• already gained experience in regulatory stakeholder interactions (e.g. Notified Body, EMA, FDA)
• are fluent in English, verbal and written, German would be a plus

Salary starting at € 4,200 gross per month based on 38.5 h/week with the express willingness to overpay depending on qualifications and experience.

We value diversity and therefore welcome all applications – regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age and sexual orientation and identity.

Severely disabled persons will be given preferential consideration if they are equally qualified.

Do you have any questions? 

Then contact me: Anita Maric (Tel.: +43 699 1414 8502).

Or apply now using our online application form.

Additional Information

• Talent Management - we develop your career
• Work life balance - flexible working hours and fully remote working possible

...and of course we offer the usual standards such as 25 days' holiday, many events, permanent employment contract and corporate benefits.