- Regulatory Affairs: You will develop and implement effective approval strategies to accelerate market access for new products and the expansion of existing product lines. You will also be responsible for the careful preparation and submission of regulatory dossiers to national and international health authorities to secure the necessary approval for our products.
- Regulatory Compliance: In this role, you will ensure that all of the company's products and processes comply with the applicable regulatory requirements. This includes the development and implementation of compliance strategies as well as supporting internal and external audits to verify compliance with all relevant regulations in the various areas of the company.
- Regulatory Intelligence: You continuously monitor regulatory developments, legislative changes and new guidelines that could have an impact on the medical technology industry. Your task is to analyze this information and proactively inform management and relevant departments about necessary adjustments in order to be able to react to changes in good time.
Regulatory Affairs Manager (m/f/d)
Heidelberg Engineering GmbH • Heidelberg
-
Full-time
Heidelberg
from today
Your responsibilities
Your profile
- You have a degree in life sciences, engineering or a related field and have in-depth knowledge of regulatory affairs, regulatory compliance and regulatory intelligence.
- You have several years of professional experience in a comparable position, ideally in the medical technology industry.
- You have in-depth knowledge of quality management standards, in particular ISO 13485, as well as a sound understanding of national and international regulatory requirements.
- Your analytical skills enable you to accurately assess complex regulatory information and understand its implications. You also have excellent communication skills to convey regulatory issues clearly and comprehensibly.
We offer
- Opportunities for mobile working to achieve a good work-life balance
- Flexible working hours on a basis of trust
- Company bike for private use as part of a bike leasing offer
- Fitness allowance for Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club
- Attractive, performance-oriented remuneration
- Training and development opportunities and a digital learning platform
- Cost subsidy for the job ticket
- Company pension scheme
- Weekly fruit basket and free drinks such as water, coffee and tea on site
- Parking facilities and bicycle storage
- Presents for company anniversaries
- Regular employee events
- Numerous discounts for online shopping through corporate benefits
It's that easy to apply!
- Step 1: Your online application
- Simply click on “Apply” and fill out the short application from. This only takes less than three minutes and can also be done on your mobile phone.
- Step 2: First Interview
- We will get back to you as soon as possible. If there is a fit, we will invite you to a first online interview.
- Step 3: In-person interview
- If the first meeting went well, we will invite you to another meeting in the office.
- Step 4: It's a match? Welcome to Heidelberg Engineering!
- You get all documents and information you need for your start and onboarding. We look forward to having you in our Team soon!
Our benefits
Employee jubilees:
To show our appreciation, we reward our longstanding employees for company anniversaries and retirements.
Bike leasing:
Whether e-bike or city bike – we offer a bike leasing opportunity to support the health of our employees and to contribute to CO2 neutrality.
Company pension scheme:
We support you in your retirement plans so that you can look forward to the future.
Employee events:
Summer and Winter events, team events or simple after-work get-togethers contribute to a supportive and collaborative culture.
Family business:
Our corporate culture can be described as international environment with a family-like working atmosphere in which you can contribute with your individual skills.
Feedback interviews:
We consider a constructive, reciprocal, and continuous feedback culture as essential for your further development and career planning.
Healthy snacks and hydration:
A weekly delivery of fresh fruits, as well as free water, tea and coffee on site provide you with a good start into the day and boost your energy.
Job ticket:
We support you with our subsidized job/Germany ticket and thereby promote an ecological alternative.
Mobile working:
We offer mobile working options for a better work-life integration and flexibility.
Modern work conditions:
We offer flexible working hours on a trust basis, 30 days of annual leave (based on a 5-day week) and additional leave days for special occasions.
Onboarding process:
Heidelberg Engineering provides you with an individual training plan for your successful onboarding.
Parking opportunities:
Whether by bike, scooter or car – we offer opportunities for parking spaces as well as a separate room to store your bike.
Stay fit:
You can join Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club with our fitness subsidy. With a wide range of gyms, classes and locations, there are plenty of opportunities for you to enjoy.
Top location:
Our attractive location in Heidelberg with direct access to the freeway, public transport and Heidelberg's main railway station make your journey both faster and less complicated.
Training and development opportunities:
Lifelong learning and continuous professional development are among the success factors in the dynamic environment in which we operate. That's why we offer a digital learning platform to expand your professional, social, methodological, and personal skillset.
Corporate Benefits:
Via our free access to our own Corporate Benefits platform we provide several discount codes for our employees with over 800 different brands in various categories such as travelling, fashion, technology, food, mobility, finance, leisure activities and many more.
Do you have any questions?
We are looking forward to supporting you!
Feel free to contact our HR Team. E-Mail copied! Copy E-Mail?
