BVI Medical

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses). BVI is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Learn more at www.bvimedical.com

Senior Clinical & Medical Affairs Specialist

Location

Poland

Posted

15 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior Clinical & Medical Affairs Specialist

BVI Medical

Role Description The Senior Clinical & Medical Affairs Specialist plays a key role in supporting clinical operations, evidence generation, and medical activities throughout the product lifecycle. This position collaborates cross-functionally to ensure clinical and medical initiatives align with regulatory and business objectives, while maintaining the highest standards of scientific rigor and compliance. - Support the execution of clinical investigations and evidence generation plans. - Contribute to clinical study design, execution, and oversight (including observational and post-market studies). - Partner with Regulatory Affairs, Quality, and R&D to support product development and lifecycle management. - Supports review of clinical documents, clinical evaluation reports, and related evidence-generation deliverables. - Provide scientific and clinical expertise to internal stakeholders. - Support interactions with external stakeholders, including investigators, clinicians, and key opinion leaders. - Ensure compliance with applicable GCPs regulations, guidelines, and internal procedures. - Monitor clinical data and contribute to safety and performance evaluations. Qualifications - Required: Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related field. - 5+ years of experience in Clinical Affairs, Medical Affairs, or related roles. - Strong understanding of clinical research methodologies and regulatory requirements. - Experience with clinical documentation and evidence generation. - Excellent communication and stakeholder engagement skills. - Ability to work cross-functionally in a global environment. - Preferred: Advanced degree (Master's, PhD, or MD) in ophthalmology related area. - Experience in medical devices and/or pharmaceutical industry. - Familiarity with EU MDR, FDA, or other global regulatory frameworks. - Experience with scientific publications and presentations. Requirements - Scientific and clinical expertise. - Analytical thinking and problem-solving. - Attention to detail and quality focus. - Strong collaboration and influencing skills. - Effective communication (written and verbal). - Ability to manage multiple priorities in a fast-paced environment. Company Description BVI® is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at www.bvimedical.com

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