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Regulatory Affairs Manager (m/f/d)
Summary
In this position you coordinate and manage regulatory activities to commercialize the Medical Devices manufactured and distributed by the Company in the International Area.
Essential Functions
* Participate on project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
* Take care of the preparation and editing of the technical and formal documentation necessary to get registrations and keep them in compliance with product changes with a particular focus on the international Area
* Manage premarketing, maintenance and renewal regulatory activities for the manufacturing site in the international Region, in collaboration with the regional regulatory team
* Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies in Europe and in the International Area
* Distribute appropriate notifications for product approvals and report on the status of approvals to appropriate company functions
* Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc.) to ensure compliance with relevant law requirements
* Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of regulatory requirements
* Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet regulatory requirements
* Assist if required during facility audits/assessments by government agencies
* Keep up to a high level of knowledge and comprehension of laws and regulations impacting on Company products
Knowledge, Skills and Abilities
* Technical Scientific University master’s degree (e.g. Chemistry, Biology, Biotechnology, Pharmacy, etc.)
* RAPS Society RAC designation is a plus
* Several years’ experience in the field of Sanitary Regulation; product conformity obtained, at least in part, in Companies in the Pharmaceutical or Medical Device sectors
* Knowledge of international regulations (for example Asia, Middle East, Latin America etc.)
* Knowledge of standards and regulations related to medical devices (EUMDR, ISO 13485, 21CFR820)
* Knowledge of the fundamentals of SAMD, digital health or AI regulations
* Knowledge of the Windows Office package
* Fluent in English (spoken and written)
* Knowledge of other languages would be a plus
* Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and / or Competent Authorities.
* Preparation of organizational procedures
* Attitude to interpersonal relationships, to efficient communication, written and oral; projects management
What we can offer you
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
* A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
* Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
* Competitive base salary
* Variable short-term & long-term incentives
* Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
Our commitment to Diversity & Inclusion:
LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
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