Regional Medical Affairs Liaison (EMEA)

Hoya Surgical Optics, Inc.; Deutschland; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Hoya Surgical Optics, Inc. is seeking a Regional Medical Affairs Liaison to advance scientific exchange, evidence generation, and external stakeholder engagement in ophthalmology.

This field-based role requires autonomy and initiative to work independently in a dynamic environment. The position supports IITs, data generation, medical education initiatives, and non-promotional scientific dialogue, with representation at congresses and advisory boards.

Competenze

• 4–6 years in Medical Affairs in ophthalmic devices or pharma.
• Experience engaging in scientific data discussions with healthcare professionals.
• Experience supporting IITs, clinical studies, or evidence generation.
• Experience in highly regulated healthcare environments.

Mansioni

• Establish and maintain peer-to-peer scientific relationships with ophthalmic surgeons, investigators, and key opinion leaders.
• Lead unbiased scientific discussions related to clinical data, surgical outcomes, and evolving standards of care in ophthalmology.
• Support IIT initiation and management in compliance with regional and/or local regulations and internal governance.
• Identify unmet medical needs and communicate actionable insights to internal stakeholders.
• Support post-market research, real-world evidence generation, and registry activities where applicable.
• Provide scientific input into medical education initiatives and non-promotional training programs.
• Represent the company at scientific congresses, advisory boards, and academic meetings.
• Collaborate cross-functionally to ensure alignment between medical strategy, clinical evidence, and regulatory requirements.
• Must operate autonomously in the field, drive execution of Medical Affairs plans, including KOL visits and IIT follow-ups.
• Support QA and Safety in review of elevated product complaints with medical input.
• Ensure all activities adhere to laws, regulations, and company SOPs.

Conoscenze

Scientific acumen

Clinical knowledge

Data translation

Regulatory compliance

English + local language

Autonomy

Formazione

MD or equivalent ophthalmology training

Descrizione del lavoro

The Regional Medical Affairs Liaison is a field-based scientific expert responsible for advancing scientific exchange, evidence generation, and external stakeholder engagement in ophthalmology. This role is responsible for high quality data discussions and support of investigator-initiated trials (IITs), operating independently of commercial promotion. The role requires a self-starter who can work autonomously, take initiative, and execute independently in a dynamic field environment. As a novel role within the organization, the Regional Medical Affairs Manager also contributes to shaping medical engagement models appropriate for ophthalmic device innovation.

E.g. This position is responsible for end-to-end supplier management, which includes oversight of supplier sourcing and selection process, qualification (audit), monitoring, development and decommissioning activities.

Duties and Responsibilities

• Establish and maintain peer to peer scientific relationships with ophthalmic surgeons, academic investigators, and key opinion leaders.


• Lead unbiased scientific discussions related to clinical data, surgical outcomes, and evolving standards of care in ophthalmology.


• Support the evaluation, initiation, and management of Investigator-Initiated Trials (IITs) in compliance with regional and/or local regulations and internal governance.


• Identify unmet medical needs and scientific data gaps and communicate actionable scientific insights to internal stakeholders.


• Support post market research, real world evidence generation, and registry activities where applicable.


• Provide scientific input into medical education initiatives and non-promotional training programs.


• Represent the company at scientific congresses, advisory boards, and academic meetings.


• Collaborate cross functionally to ensure alignment between medical strategy, clinical evidence, and regulatory requirements.


• Must demonstrate the ability to operate autonomously in the field, proactively identify priorities, manage activities with minimal direction, and independently drive execution of approved Medical Affairs plans and stakeholder engagements, including planning and conducting KOL visits, identifying and escalating scientific insights, coordinating follow-up on IIT opportunities, and prioritizing congress and field activities based on medical strategy.


• Support Quality Assurance and Safety in the review and follow-up of elevated product complaints when needed, including providing medical and scientific input within the scope of Medical Affairs.


• Ensure all activities adhere to applicable laws, regulations, and company SOPs governing Medical Affairs activities.

Authority

• Independently engage in non-promotional, scientific exchange with healthcare. professionals, investigators, and academic stakeholders within the defined therapeutic and technological scope.


• Respond to unsolicited scientific inquiries using approved data, peer-reviewed literature, and fair-balanced scientific information, in accordance with company SOPs and local regulations.


• Exercise professional judgment to prioritize external scientific engagements and allocate field time based on medical strategy and unmet scientific needs.


• Identify, evaluate, and communicate scientific insights, research opportunities, and unmet medical needs from the field to internal stakeholders.


• Support the scientific evaluation of Investigator-Initiated Trial (IIT) concepts, including providing input on scientific feasibility and alignment with medical strategy, while final approval decisions remain with designated internal governance bodies.


• Represent Medical Affairs in scientific forums, congresses, and advisory interactions as a subject‑matter expert, within approved scope and training.


• The Regional Medical Affairs Manager does not have authority to:


• Engage in promotional selling activities or commercial decision‑making.


• Approve financial commitments, contracts, or study funding.


• Make commitments regarding product supply, pricing, or regulatory outcomes.

Requirements

Experience

• [Prior experience (4-6 years) in Medical Affairs, such as Regional Medical Affairs Manager, Medical Advisor, or Scientific Affairs roles, within an ophthalmic device or pharmaceutical company.


• Demonstrated experience engaging in scientific data discussions with healthcare professionals.


• Experience supporting or managing Investigator-Initiated Trials (IITs), clinical studies, or evidence generation activities.


• Experience working within highly regulated healthcare or life sciences environments.]

Skills/Accreditations

• [Strong scientific and clinical acumen in ophthalmology.


• Ability to translate complex clinical data into meaningful scientific dialogue.


• Working knowledge of regional and/or regional biodevice industry and medical affairs compliance standards.


• Excellent communication skills in English and regional/local language (written and spoken).


• High degree of professionalism, autonomy, ethical judgment, and the ability to work independently as a self-starter.]

Academic Qualifications

• [Advanced degree in a scientific or clinical discipline (MD or equivalent) with specialty training in ophthalmology.]