Medical Affairs Director Structural Heart Emea

vor 2 Wochen

Zug, Schweiz Abbott Laboratories Vollzeit

**A Brief** Overview**

Provide medical and scientific leadership for all activities within the Structured Heart Medical Affairs scope. Provide EMEA Leadership for medical affairs activities throughout the product lifecycle across all Structural Heart. Lead strategic programs for post-market vigilance and medical device reporting (MDR) to assure identification of important safety concerns/issues are evaluated and reported correctly and meet regulatory requirements. Lead strategic improvement of clinical research practices to prepare for successful outcomes and emerging regulations. Provide leadership in ensuring that adequate medical input is incorporated into product development processes, field actions decisions and any other post-market surveillance activities.

**What you will **do**

Main Responsibilities:

- Responsible for developing and maintaining Corporate policies and procedures that meet regulatory requirements.
- Provide strategic review and input to current and emerging medical and/or safety issues related to Abbott products.
- Provide strategy and input to ensure that medical and clinical perspectives are incorporated into product design and throughout the product lifecycle.
- Provide strategic leadership for medical personnel across the Abbott businesses.
- Provide business support and consultation as needed for medical activities at Abbott businesses, including compliance issues, preparation for and participation in external inspections, and process improvement activities.
- Provide medical review for corporate advertising and promotional materials. Represent Abbott on key outside committees (e.g., AdvaMed)

Accountability:

- Works broadly across divisions to facilitate and support medical, clinical, product development risk management, field actions and vigilance/MDR reporting compliance
- related activities.
- Must evaluate Abbott businesses' product development risk management, clinical operations, customer complaints, field actions and post-market vigilance reports to assist the businesses in making judgments and assessments in regards to patient safety, risk management, Bio-Ethics and compliance.
- This requires careful balancing of risk versus benefit, and the ability to recommend strategies for remediation of potential gaps, often under a number of constraints. Decisions must be made promptly with clear understanding of their impact on Abbott and all divisions.
- This requires significant medical and technical knowledge, and familiarity with diverse global regulatory requirements.
- Must evaluate and analyze external data to identify industry and regulatory trends; compare the external trends with the internal Abbott data; use the outcomes of the analyses to assess division performance and assist in the development of improvement plans to ensure that they are appropriately implemented. Work mostly independently, but will require some oversight/guidance.

**Qualifications**
- Doctorate Degree (± 19 years) MD, or equivalent, with specialty training in Internal Medicine, General Practice, or other discipline relevant to Abbott devise/diagnostic businesses. Board certification and experience in clinical practice preferred.
- M.D. with minimum 3-5 years relevant device/diagnostic/pharmaceutical/nutritional industry experience or demonstration of equivalent experience from another industry.
- Leadership Skills: Ability to make good decisions in a timely manner based on the available information.
- Able to demonstrate a high level of strategic thinking, business acumen and influence with fact-based information. Ability to effect change via influence rather than direct authority.

**Profile**
- Advanced degree preferred (PhD and MD), with a strong background in clinical medicine, cardiology and SH. Deep knowledge and experience with catheterization laboratory Technology; and a minimum of 10+ years work experience or equivalent combination.
- Knowledge of cardiac devices is essential, and a background in safety or product performance is a plus.
- Business experience preferred within the Asia, Australia and Pacific medical products market.
- Experience in leading teams and peer leadership interaction.
- Excellent written and communication skills.
- Exceptional technical skills and knowledge.
- Polished presentation skills and a well-recognized list of peer-reviewed publications are important as this position may be asked to represent the company to physicians and healthcare forums.

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