Legal Counsel EMEA mwd

Posted 6 Days Ago
Remote
Junior
Healthtech
The Role
The Legal Counsel EMEA will provide strategic legal guidance on healthcare regulatory and compliance matters in the Medical Technology division, focusing on the EMEA region. Key responsibilities include interpreting laws related to medical devices, ensuring compliance, advising on commercial matters, negotiating contracts, and managing legal expenses.
Summary Generated by Built In

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
The Company
HQ: Bad Homburg
42,197 Employees
On-site Workplace

What We Do

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day.

Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life.

Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.

Similar Jobs

Roblox Logo Roblox

Lead Counsel, India

Computer Vision • Gaming • Software • Virtual Reality • Web3 • Metaverse
Remote
Gurugram, Haryana, IND
2500 Employees

Enveritas Logo Enveritas

General Counsel

Machine Learning • Other
Remote
6 Locations
102 Employees
Remote
8 Locations
147 Employees

Invisible Technologies Logo Invisible Technologies

Senior Counsel, Commercial (Tech-focused)

Artificial Intelligence • Information Technology • Machine Learning • Professional Services • Software • Analytics • Consulting
Remote
8 Locations
391 Employees

Similar Companies Hiring

InterSystems Thumbnail
Software • Machine Learning • Healthtech • Database • Big Data • Artificial Intelligence • Analytics
Boston, MA
1800 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account