Specialist Regulatory Affairs Operations and Labelling (f/m/d)

At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment, you can grow on your job every day. At HARTMANN, we believe in the difference you can make.

Join our team as

Specialist Regulatory Affairs Operations and Labelling (f/m/d)
DEU-Heidenheim

At HARTMANN, you have the opportunity to become part of a global team. As a Specialist Regulatory Affairs Operations and Labeling (f/m/d), we offer you a varied and challenging position in an international environment. Here you can develop your skills and play an active role in ensuring product quality and regulatory product conformity. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

This position is also possible on a part-time basis.

Responsibilities:

1. In this cross-functional and global role, you will ensure the labelling and implementation of products on time according to regulatory requirements.
2. Global monitoring and improvement of regulatory product documentation and conformity assessments.
3. You will be responsible for the master files of the package inserts, labels and artwork and check them for correctness and the necessary labeling requirements in the review and approval process.
4. Develop proposals to improve the IT infrastructure for the management of regulatory product documentation.
5. Provide strategic and technical consulting on regulatory issues.
6. Final evaluation of product-related regulatory requirements.

Qualification:

1. University degree in science or technical sciences or an equivalent qualification.
2. Ideally initial professional experience in the medical device environment or another regulatory field of work.
3. Knowledge and/or experience in the areas of medical devices, technical documentation and regulatory product documentation, conformity assessment and post-market surveillance.
4. Ideally a strong interest in and knowledge of electronic regulatory document control and management systems and associated processes.
5. Open and competent attitude when working with internal partners.
6. IT affinity and proficiency with the MS Office package.
7. Strong communication skills as well as persuasiveness and assertiveness.
8. Fluent written and spoken German and English.

Benefits:

1. Flexible working conditions, such as flexible working hours and mobile working.
2. International Mobile Working.
3. Attractive ways of combining work and family life, e.g. childcare subsidy.
4. 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement.
5. Company pension plan with attractive employer contribution incl. matching model for deferred compensation.
6. Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop.
7. Access to over 6000 fitness and yoga studios, swimming pools as well as CrossFit and bouldering halls (EGYM Wellpass).
8. Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break, etc.
9. Job Bike Leasing.
10. Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform.

Shape a career that’s focused on healthcare customers, fit for the future and grounded in a culture of trust and openness.

Apply now via our online platform.

Your personal contact:
Isabel Proske

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