Legal Counsel EMEA mwd

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.