Overview
RA manager – Medical devices Jobs in Šamorín, Trnava Region, Slovakia at Sky Medical a.s.
Title: RA manager – Medical devices
Company: Sky Medical a.s.
Location: Šamorín, Trnava Region, Slovakia
The Regulatory Affairs Manager is responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices . The RA manager translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include; preparing, MDR and 510k submissions; prepare Technical File, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.
Responsibilities
Team with business unit to provide regulatory support for new products and changes to existing products. Work with technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Prepare CE Mark Technical Files andFDA submissionfor product changes and/or new products
Review Change Orders and assess regulatory & labeling impact of product changes
Preparation and maintenance of annual renewals of Establishment Registrations
Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing and provide regulatory support when needed.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
Determination of regulatory submission requirements according to domestic and international regulations related to changes/new products/claims.
Maintain / Index / Organize Regulatory library.
Maintain technical knowledge of devices in area of responsibility.
Maintain up-to-date on global regulatory requirements and assist in keeping company informed of regulatory requirements.
Review/Prepare Standard Operating Procedures (SOPs) as needed.
Perform additional duties as assigned
Qualifications
Strong working knowledge of medical devices regulations and terminologies.
Excellent written and oral communication, and technical writing and editing skills.
Ability to write clear, understandable technical documentation.
Skilled at analyzing and summarizing data.
Proficient with Microsoft Office.
Ability to manage and prioritize multiple projects.
Ability to follow written and verbal directions with a high level of accuracy.
Ability to work independently with minimal supervision.
Extreme attention to detail.
Effective interpersonal skills.
Minimum Bachelor’s degree in a scientific related field or equivalent combination of education/experience. Advanced degree preferred.
Minimum 2 to 4 years related experience, or equivalent combination of education and experience, required.
Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13485)
RAC Certification, preferred.
International medical device regulatory submission / approval experience including EU, preferred
