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- Aufgaben: Lead and support key regulatory projects to ensure compliance with medical device regulations.
- Arbeitgeber: Join MED-EL, a global leader in innovative hearing solutions with over 2,800 employees.
- Mitarbeitervorteile: Enjoy flexible hours, employee discounts, and a supportive international work environment.
- Warum dieser Job: Make a real impact by helping people hear better while growing your career in a collaborative setting.
- Gewünschte Qualifikationen: A higher degree in legal, science, or engineering with at least 2 years of relevant experience preferred.
- Andere Informationen: Fluency in English is required; advanced German is a plus. Apply now to make a difference!
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
About MED-EL
MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world.
Your Tasks
Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance.
- Lead, organise and support key regulatory projects / tasks and regulatory compliance initiatives
- Organise and support preparation of regulatory submissions, licence renewals, registrations and change notifications to international authorities
- Organise and maintain regulatory documentation to meet regulatory requirements
- Provide regulatory intel to product development projects
Your Profile
- Higher degree and/or experience preferably in a legal, science or engineering discipline, with a health science or biomedical component e.g. HTA, public health, clinical research, regulatory affairs
- At least 2 years medical device or regulatory affairs work experience is strongly preferred, graduates with any biomedical related experience e.g. in pharmaceutical industries, clinical research or health technology assessment are also welcome
- Excellent English (spoken and written) is required, advanced German strongly preferred
- Eager to learn, attention to detail, proven problem-solving and organisational skills, as well as a collaborative personality
Your Benefits
- Central Location
- Employee Discounts
- Flexible Hours
- International Environment
- Onboarding
- Workplace Well-Being
Interested?
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
Your Contact Person
If you have any questions please contact Caroline Schenk.
caroline.schenk@medel.com
Please apply in English!
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
Your Contact Person
If you have any questions please contact Caroline Schenk.
caroline.schenk@medel.com
Please apply in English!
Regulatory Project Associate (m/f/d) Arbeitgeber: MED-EL
Kontaktperson:
MED-EL HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory Project Associate (m/f/d)
✨Tip Number 1
Familiarize yourself with the regulatory landscape specific to medical devices. Understanding the key regulations and standards that govern this industry will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in medical devices. Engaging with industry experts can provide valuable insights and may even lead to referrals for job openings.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs by following relevant publications and attending webinars. This knowledge will show your proactive approach and eagerness to learn during the interview process.
✨Tip Number 4
Prepare to discuss specific regulatory projects or experiences you've had in the past. Being able to articulate your contributions and the outcomes of these projects will highlight your problem-solving skills and attention to detail.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory Project Associate (m/f/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Project Associate position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory affairs or medical devices. Provide specific examples of projects you've worked on that align with the tasks mentioned in the job description.
Showcase Language Skills: Since excellent English is required and advanced German is preferred, make sure to highlight your language proficiency clearly in your application. If you have certifications or relevant experiences, include those as well.
Craft a Compelling Cover Letter: Write a personalized cover letter that reflects your enthusiasm for the role and the company. Mention why you are interested in MED-EL and how your skills and experiences make you a great fit for their team.
Wie du dich auf ein Vorstellungsgespräch bei MED-EL vorbereitest
✨Show Your Regulatory Knowledge
Make sure to brush up on the latest regulations and standards in the medical device industry. Being able to discuss specific regulations relevant to MED-EL's products will demonstrate your expertise and commitment to compliance.
✨Highlight Relevant Experience
Prepare to discuss your previous experience in regulatory affairs or related fields. Be ready to provide examples of projects you've worked on, especially those involving regulatory submissions or compliance initiatives.
✨Demonstrate Problem-Solving Skills
Think of instances where you faced challenges in regulatory projects and how you overcame them. Sharing these experiences will showcase your problem-solving abilities and your proactive approach to regulatory compliance.
✨Communicate Clearly in English
Since excellent English skills are required, practice articulating your thoughts clearly and concisely. If you have advanced German skills, be prepared to mention them, but focus on your English proficiency during the interview.
