Clinical Affairs Manager (m/w/x)

TN Germany; München; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Affairs expert to lead clinical evaluation strategies and ensure compliance with regulatory requirements. This role involves the planning and execution of clinical documentation, project management, and collaboration with international teams. The ideal candidate will have a strong background in medical devices, excellent analytical skills, and a commitment to driving clinical excellence. Join a dynamic team where your expertise will shape innovative products and contribute to meaningful advancements in healthcare. If you thrive in a fast-paced environment and are passionate about improving patient outcomes, this opportunity is perfect for you.

Qualifikationen

• Minimum four-year college degree in optometry, medicine, or natural sciences.
• At least 5 years of experience in Clinical Affairs in the medical device industry.

Aufgaben

• Participate in complex project product development and implement clinical evaluation strategies.
• Independently plan and maintain clinical documentation for regulatory purposes.
• Support clinical/regulatory affairs teams worldwide in product registrations.

Kenntnisse

Clinical Evaluation

Project Management

Regulatory Knowledge

Data Interpretation

Medical Writing

Analytical Skills

Communication Skills

Ausbildung

Degree in Optometry, Medicine, or Natural Sciences

Jobbeschreibung

Your role

1. Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product.
2. Responsibility for budget and time planning for the entire clinical strategy and for compliance with this, taking into account economic aspects and project risks as well as defining minimization measures.
3. Independently plan, generate and maintain clinical documentation for regulatory purposes (e.g., Clinical Evaluation Plan and Report, clinical content for regulatory submissions), including continuous gap analysis and conclusion on sufficiency of clinical evidence, adapt clinical strategy when necessary.
4. Planning and execution of CA tasks of post-market surveillance including database analysis and literature search, with regular updates of clinical assessments.
5. If necessary, select and coordinate external service providers for the aforementioned activities.
6. Create and/or review manuscripts for scientific publications.
7. Review and approve product-specific marketing materials and publications.
8. Support clinical/regulatory affairs teams worldwide in product registrations.
9. Report on project progress.
10. Act as an internal consultant/subject-matter expert for the adaptation and improvement of Clinical Affairs processes.

Your profile

1. Education: Minimum four-year college degree in optometry, medicine, medical technology/engineering, or natural sciences.
2. At least 5 years of experience in Clinical Affairs/Clinical evaluation in the medical device industry or with contract research organizations.
3. Good knowledge of relevant regulatory requirements for clinical trials for medical devices (ICH-GCP, ISO 14155).
4. In-depth knowledge of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines).
5. Good knowledge in biostatistics, data interpretation, and critical reading of publications.
6. Good knowledge of regulatory requirements for CE, FDA, NMPA, Health Canada, etc.
7. Demonstrated qualities in project management and medical writing.
8. Strong analytical skills coupled with creativity and intuition.
9. Commitment, creative drive, and strong communication and organizational skills in an international environment.
10. Very good oral and written communication skills in English.