Director Legal Regulatory - EMEA Area

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Director Legal Regulatory - EMEA Area, MaidenheadClient:

Abbott

Location:Job Category:

Other

EU work permit required:

Yes

Job Reference:

f22ffc2fd0fc

Job Views:

6

Posted:

14.02.2025

Expiry Date:

31.03.2025

Job Description:

We are seeking an exceptional Regulatory Attorney with expertise related to European (the European Commission, EMA, MHRA, BfArM, RZN) regulatory matters to join our global Legal Regulatory and Compliance team. Experience related to Middle Eastern (Ministries of Health, SFDA) regulatory matters is beneficial. The Regulatory Attorney will support Abbott’s Medical Device, Diagnostic, Nutrition, and Established Pharmaceutical businesses on legal topics relating to the regulation of Abbott’s product offerings, from product development and submissions to manufacturing and quality, product cybersecurity, and marketing practices. This is an individual contributor position reporting to Abbott’s Division Counsel, Regulatory.

About Abbott Legal:

We are legal professionals charged with driving Abbott’s businesses forward. We engage as business leaders, beyond providing legal advice, to solve problems for the company and the customers and patients we serve. A position in the Abbott Legal Division provides an opportunity to learn and grow. As our company grows and evolves, so do our roles. We engage in meaningful, challenging, and interesting work on a global scale. This continual evolution provides experiences and opportunities to grow both in the depth of legal expertise as well as breadth of leadership. We value diversity of backgrounds and experiences in our teams. This is integral to our inclusive and collaborative environment. We expect and encourage our employees to be holistic thinkers and we are expected to see the big picture and impact of our advice.

Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence. Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference.

Core Job Responsibilities:

• Responsible for counselling on European, Middle Eastern, and African laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, manufacturing, and marketing of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals, as well as inspectional, product quality/safety, and post-marketing compliance issues.
• Acts as a subject matter expert on food and drug laws and regulations in EMEA;
• Collaborates with cross-functional teams and counsels a variety of clients (including commercial, regulatory affairs, and quality assurance professionals) on moderately complex legal regulatory issues within the EMEA region, such as product design and formulation, product submissions, product field actions, patient complaints, agency inspections, advertising and promotion, and manufacturing requirements;
• Resolves moderately complex to complex legal regulatory matters with minimal supervision;
• Keeps abreast of changes in laws and regulations that may impact the regulation of Abbott’s product offerings, identifies opportunities to influence content, engages in external influencing efforts; and analyses and supports advance planning for implementation of new regulations/requirements;
• Interacts and provides legal and strategic guidance to senior management and functional organizational leadership;
• Provides training and education to legal division and other Abbott employees;
• Helps select and directs the work of outside counsel, defines project objectives, and manages project to ensure the work, strategy, and costs meet Abbott’s expectations;
• Conducts regulatory and quality due diligence in connection with potential M&A or other business transactions in EMEA.

Position Accountability/Scope:

• Advises multiple Abbott businesses on legal regulatory matters.
• Advises Managers, Directors, General Managers, Division Vice Presidents, and executive leaders.
• Advises legal department managers of significant project developments and complex legal issues.
• Helps manage departmental budget, working with Divisional Vice President and other regulatory attorneys.

Training/Experience Required:

• Generally, 7+ years of experience and demonstrated expertise in providing legal counsel on medical device, nutrition/food, and/or diagnostic regulatory and quality matters with a major corporation or law firm; device cybersecurity proficiency is desirable; government experience is also beneficial.
• Must have demonstrated ability to influence others, to perform successfully in cross-functional teams, and to lead, mentor, and develop others.
• Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment.
• Successful candidates are team players and servant leaders who not only possess top-notch legal skills, but display excellent interpersonal, strategic thinking, communication and organizational skills.

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