Legal and Compliance
Legal Counsel EMEA mwd
Address: Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany
Job ID: R0129966
- Overview
- Job Description
- Success Profile
- Rewards
- Video Testimonials
- Connect
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Job Description
Position Purpose:
The holder of this position reports to the Senior Legal Counsel based in Bad Homburg, Germany and acts as a strategic legal partner to the various businesses of the Medical Technology division by providing practical and business-oriented guidance on healthcare regulatory, commercial, government policy, enforcement and compliance matters, with particular emphasis in the EMEA region.
Primary Duties:
- Serves as central point of contact for management of the Medical Technology businesses for legal issues relating to European medical device and pharmaceutical law, the German Social Code – Book V (SGB V) and general healthcare law
- Interprets and applies the HWG (German law on the advertising of medicinal products), UWG (German law on unfair competition), and questions of antitrust and copyright/trademark law
- Monitors, evaluates and interprets all applicable healthcare regulatory requirements; assures compliance with European and foreign healthcare regulatory authorities and the Company’s standards
- Partners with country and global Regulatory Affairs/Quality Assurance teams through the entire life cycle of our products (pre-approvals/pre-clearances, post-market reporting, recalls, inspections and quality system regulations)
- Provides proactive operational legal advice on sales and marketing materials and communications for both internal and external audiences related to the Company’s technologies
- Provides strategic legal advice to research and development departments
- Negotiates, drafts and reviews contracts in the aforementioned areas of law
- Serves as contact for legal questions related to healthcare law compliance
- Selects and supervises outside counsel, when such counsel is required, and efficiently manages legal expenses
- Supports the Company, as requested, in interactions with regulatory authorities or with other Company subsidiaries internationally
- Performs other duties as assigned, including supporting legal matters related to other business regions.
Critical Deliverables:
- Provides proactive, practical and business-oriented legal advice and counsel to internal stakeholders on legal issues in healthcare law, quality and regulatory affairs pertaining to the EMEA market
- Acts as an accessible, visible, responsive and go to subject matter expert for the businesses in order to assist the assigned businesses in their effort to comply with all applicable rules while also meeting business goals
- Identifies legal risks and contributes to the development of the legal approach in accordance with commercial and corporate priorities and policies
- Assures compliance with FME’s corporate guidelines, compliance and governance policies and implements supporting processes and controls together with local and regional compliance department
- Utilizes subject matter expertise to help the business meet their goals and the company goals
- Supports current business activities by ensuring legal backing on customer-oriented, value-adding solutions
- Acts as the legal point of contact for certain internal audits
Requirements:
- Law degree from an accredited college or university required
- Licensed to practice law in the country where residing
- LL.M. on top a plus
- 2-5 years related experience as a practicing law, either at a law firm or in-house, ideally a combination of both, advising on healthcare law and compliance related to the manufacturing, registration, promotion and sale of medical technologies
- Attention to detail yet ability to see the big picture
- Excellent written and oral communication skills
- Strong interpersonal skills with the ability to communicate with all levels of management and staff through diplomacy and tact
- High level of intrinsic motivation, ability to manage change and ambiguity
- Collaborative work style and excellent communication skills within and across teams
- Ability to lead tasks where necessary
- Strong intellect and business acumen
- Strong drive for results and sense of ownership
- Extremely responsive, organized and a strong communicator
- Fluency in a second language after English
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Communicator
Compassionate
Detail Oriented
Relationship Expertise
Facilitator
Leadership
“You have a lot of independence...so the doctors trust you. You have to be able to make decisions on your own.”
Lesly,
Inpatient Services RN
Inpatient Services RN
We've got your back.
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving
By submitting your information, you acknowledge that you have read our privacy policy consent to receive email communications from Fresenius Medical Care AG.