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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
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Provides strategic legal advice to research and development departments
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Negotiates, drafts and reviews contracts in the aforementioned areas of law
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Serves as contact for legal questions related to healthcare law compliance
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Selects and supervises outside counsel, when such counsel is required, and efficiently manages legal expenses
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Supports the Company, as requested, in interactions with regulatory authorities or with other Company subsidiaries internationally
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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
What you need to know about the Sydney Tech Scene
From opera to comedy shows, the Sydney Opera House hosts more than 1,600 performances a year, yet its entertainment sector isn't the only one taking center stage. The city's tech sector has earned a reputation as one of the fastest-growing in the region. More specifically, its IT sector stands out as the country's third-largest, growing at twice the rate of overall employment in the past decade as businesses continue to digitize their operations to stay competitive.
