Description:
Location: Germany

Schedule: Full-time, Permanent, Office Based

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Regulatory Affairs Specialist to join a TOP pharmaceutical company in Germany, within their Medical Device Ophthalmology area.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

The Medical Device Regulation project team will be responsible for raising the product compliance of legacy products in areas like clinical, post-market surveillance, labelling, technical documentation, biocompatibility, QMS systems etc. on a level which allows CE-marking and compliant distribution in accordance with the new Medical Device Regulation until May 2024.

This team will be responsible for all Medical Device Regulation related Regulatory tasks for the Sponsor which have to be supported in the EMEA region and which require detail knowledge of Medical Device regulations and respective guidelines (like common specifications or MDCG guidelines).

The Regulatory Affairs Specialist has the overall goal to achieve the CE certification of all Company products according to the new MDR regulation until May 2024.

Main Job Tasks and Responsibilities:

• Evaluation what impact the new requirements have and what additional actions have to be added to the existing documentation
• Reworking the existing documentation for all devices / device families to fulfil the new Technical Documentation for all Medical Devices.

Regulatory related areas to be reviewed:

• Regulatory understanding for Intended Purpose, Indications, Contraindications, Intended User
• Regulatory process to generate a device specification
• Regulatory content of an Instructions for Use
• Regulatory content of device Labelling
• Design Verification and Design Validation e.g. for Biocompatibility, Sterilization, Packaging Performance etc.
• Aim of the entire MDR project is to conduct the transition process from MDD to MDR. As a result, the new certification of the devices under MDR shall guarantee the continuation of sales in the European market in the future (after May 2024).
• Detailed task description without personal reference, which reveals the independency of the service provision
• The upcoming regulatory requirements are published but the interpretation of the text is still a moving target due to newly published guidances and specifications.
• Independent writing of Technical documentation for Ophthalmology Device products and final document review by Company before submission
• Technical consultation on interpretation of MDR, MDCG or common specifications on request by the MDR project teams
• Independent review of the MDR compliance of all documents which are part of a Technical File, with a special focus on Regulatory documents like labelling, product classification or the main text of the technical documentation
• Providing input to the MDR teams for discussions with our Notified Bodies, mainly questions from the update of the Technical documentation for clarification with the Notified Body. The contractor should help the clarification process with the Notified Body (external certification bodies) by creating presentations to facilitate the discussions
• Contact point for MDR related customer requests on Regulatory information in EMEA and a response to the request will be provided by the contractor
• Contact point for Regulatory related audit questions for the MDR audits in 2021 (2 Notified Body audits planned in EMEA)
• Independent review and test of the new EUDAMED database

Education and Experience:

• Physician (MD or equivalent), generally requires 2-5 years of regulatory experience
• Board Certification (if US) preferred
• Medical specialization preferred
• Demonstrated skills in new Medical Device Regulation
• Experience with Health Authority presentations is preferred
• Able to plan work to meet deadlines and effectively handle multiple priorities
• Excellent verbal and written communication skills, including formal presentation skills.
• Fluent in written and spoken English
• Proficiency in Word and PowerPoint is desired

Specific Role Requirements and Skills:

• Knowledge of on MDR regulations and respective guidelines
• Connect, collaborate and build consensus across relevant functions
• To create and submit the TechFiles for the Medical Device SV product family to the Notified Body.
• Submission of the SV Technical Files to Company Notified Body in 2021
• To achieve the CE certification of all our products according to the new MDR regulation until May 2024

The Benefits of Working for TalentSource in Germany:

• 30 Euro net Internet cost reimbursement per month
• Additional Accident Insurance, fully covered by the company
• 25 vacation days (but up to 30 days, depending on negotiation)
• Possibility of salary conversion for additional pension insurance
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Key words: Regulatory Affairs Specialist, Regulatory, Medical device, Regulation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
Skills: Medical Devices, Regulatory, English Location: Germany Share:

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