Empleo de director de asuntos reglamentarios/directora de asuntos reglamentarios en Darmstadt-Dieburg (Alemania)

Stellenangebotsbeschreibung:

At Azenta Life Sciences, it is our strong belief that our employees are critical to our strength, success, and impact we have on the world, and we are always looking for extraordinary talent across all facets of our organization.

Every moment our world is kept waiting for a discovery, a therapy, or an essential innovation, impacts the lives of people who need them. If you want to reach new heights in the pursuit of scientific progress and make a difference in the world, we want to hear from you!

Our team is seeking a new talent, starting at earliest possible time:

Regulatory Affairs Manager (m/f/d)

Your working location: Remote-based with travel as needed.

How You’ll Add Value

The Regulatory Affairs Manager accompanies our various development projects about any regulatory issues. Risk management and the supervision of usability studies are the responsibilities of this position. An important part of the position is the evaluation of RoHS / REACH conformity in connection with biocompatibility. The preparation of clinical evaluations for our medical devices is an essential part of the job.

The maintenance of the technical documentation according to MDR specifications is another core task of this position, which must be carried out extremely precisely and conscientiously as well as regularly. In this position, a regular exchange with various departments is a prerequisite to achieve the best possible results. An example of this is the conformity assessment procedure, where coordination skills are required. Communication with the responsible national and international approval authorities. The candidate will be expected to have excellent verbal and written communication skills to communicate status to management as well as external approval authorities. The candidate is expected to successfully deal with tight deadlines, conflict resolution, be open to criticism and be capable to be a team player.

Continue development of global regulatory strategy for current and potential medical devices.

Compiling, maintenance, and submission of technical files to the national and international authorities / bodies.

Responsible for compliance with regulations and standards relating to medical devices.

Assessment / alignment of the conformity of medical devices, regulatory and compliance topics in the relevant sites.

Maintain compliance of registered medical devices

Communication with the responsible national and international approval authorities.

Work with factories’ QA, QC, and R&D teams as needed for regulatory information.

Coordinate with relevant interfaces for Significant Change Notifications to notified bodies (TUV SUD, DEKRA, etc.) if applicable.

Liaison with external consultants as needed to accelerate projects and get products to market.

Liaison with external RA entities, i.e. in China, to bring products to market efficiently.

Coordinate global customer Regulatory Affairs requests and assign to owners in EU, US, and/or UK as applicable (or utilization of 3rd party resources).

Monitor Regulations and standards and report on changes and impact analysis of the change to various product lines.

Develop or revise training materials for regulatory processes (audience could be R&D, Operations and/or executive management).

Product specific projects:

Barkey’s S-Line and Plasmatherm 510(k) maintenance or special 510(k) submissions if applicable.

In Luxembourg, support R&D for potentially redesigned products due to changes in regulations (i.e., WHO PQS).

Strategies for US Manufactured product via Contract Manufacturing model for EU MDR.

Or other potential Projects / products.

Other tasks relevant to RA Manager as needed such as factory visits and global forums related to RA (i.e. Munich Medical Device Forum by TUV).

Appointed to be PRRC for the relevant sites.

What you will bring

Technical studies (electrical engineering, medical technology, mechanical engineering, physics, etc.) or comparable

Proven experience in the field of regulatory affairs in medical technology

Knowledge of national and international regulations relevant to regulatory affairs

Goal-oriented approach and a high degree of independence

Ability to work across the organization.

Furthermore, you have a very good command of German and English, both written and spoken

Ability to think creatively, take initiative, and work independently.

Excellent communication, planning, and organizational skills with proven record of being able to meet tight deadlines while delivering high quality.

The ability to question yourself and your working methods with the aim of further developing yourself and the company.

Our Offer

Contribute to innovative cell therapies and be a part of revolutionary cancer therapies.

Flexible working hours and the possibility of "mobile working" are a matter of course for us.

Take advantage of the operational opportunities in a growing, modern, and innovative company within the health care/life science industry.

Experience an intensive exchange of experiences and close cooperation in a worldwide network with our customers, friends and partners.

We offer participation in national and international company events.

After your initial training, you will receive regular training and further education opportunities that are tailored to your needs.

A workplace that promotes your maximum

You will participate in capital-forming benefits, numerous corporate benefits, the possibility of a job bike, etc.

Experience a corporate culture that is characterized by appreciation, communication at eye level and humanity.

Contact

eMail: Donna.Rhodesazenta.com

To apply for this role, please follow the "apply" link and create your applicant profile in a few simple steps. Please have your attachments ready for this (cover letter, CV, certificates or references if applicable).

Advice: Upload both cover letter and resume under the "CV" section.