Regulatory Affairs Specialist / Deputy PRRC

Please do not apply if you are located outside GermanyAbout FreyrFreyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.Why Freyr?At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory serviceJoin Our Team:If you\’re ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions📢 To Apply:Please apply to this job post or you can visit our Careers page for more openingsVisit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application. Don\’t miss this chance to be a part of Freyr\’s expansion and make your mark in the world of regulatory services. Let\’s redefine regulatory excellence together!Title : Regulatory Affairs Specialist / Deputy PRRCLocation : GermanyExperience : 3+ years in MDR and proficiency in German language is a mustPrimary Responsibilities:To perform the duties of Person Responsible For Regulatory Compliance (PRRC) as per the Article 15 of Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).To work as a QA/RA expert and ensuring manufacturer’s compliance with the MDR and IVDR.To prepare and review SOPs and compliance documents to build and update the compliance framework.Act as a Point of contact for Notified Bodies/Competent Authorities for all compliance and registration activities.Support for the registration process for the target products in terms of gap assessments of internal regulatory systems for relevant manufacturers. Review and gap assessment of the technical files and documents required to EU compliance for manufacturers.. Delivery of regulatory intelligence projects including guideline interpretation, regulatory precedence, regulatory landscape and providing key information and analytics to Freyr’s clients. To prepare the Artefacts (e.g. check list, presentations) required for the project delivery. Provide PMS support for the projects where responsible as PRRC.To arrange support from cross functional teams for any technical inputs required during client meetings.To liaise with various cross functional teams (internal and external stakeholders) – Sales, Freyr X, Client services and with clients for monitoring the timelines and overall progress of the project deliverables and maintenance activities. Communicate withmanufacturers and Competent Authorities /MHRA / Notified bodies as required and archive all relevant communications.Manage day-to-day operational aspects of assigned project including customer related activities and deliverables.Proactively anticipate and identify risks/ issues areas and alert stakeholders appropriately for respective projects.To ensure the project deliverables are archived as per internal procedures.To support audits from notified bodies and competent authorities from medical devices function.Developing and maintaining project metrics, timelines and deliverables including project plans, trackers and tools for assigned projects.To support various database and resgitration portal registration and maintenance in the Europe region.Ensure compliance for the products supported by Freyr in Europe and Switzerland with MDR/IVDR/MDD/IVDD/AIMDD/Swiss MedDO, with respective regulation in the country.Secondary Responsibilities:To analyze regulations and guidelines for compliance requirements and provide regulatory strategy for new Medical device registrations as per regional requirements.To keep abreast of evolving regulatory landscape for Europe as a region and understanding the new regulations, impact of new regulations for current clientele.To participate in daily meetings, team meetings, organizational meetings, and customer meetings.Complete the training activities in compliance with Freyr QMS, IRMS manual and trainingactivities organized by freyr learning academy and regulatory changes in Europe.Excellent management skills, both of individuals and projects.Ability to resolve conflicts.Ability to translate our strategy and goals into a regulatory/compliance program. Based on requirements, ability to provide regulatory approach.Must have an ability to accomplish goals according to business needs.Qualifications:Bachelor\’s degree in Life Sciences, Engineering, Biological Science, Pharmacy or related technical discipline, desirable.3+ years\‘ experience in Regulatory Affairs for an medical device company, required.PRRC Qualifications (Required Experience and Education), one of two optionsA diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline. Any qualification acquired outside the EU, including any university diplomas or certificates, has been recognized by an EU Member State as equivalent to the EU corresponding qualification.ANDAt least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. The professional experience in regulatory affairs or in quality management systems are related to the EU requirements in the field – MDCG Guidance 2019-7.