**Regulatory Affair Manager AMD** will develop and manage products Registration strategy implementation within Abbott Molecular Division to accomplish planned objectives such as new innovative molecular platform registration, including reagents and consumables; obtain Registration for projects in pipeline; follow up Remediation Plan Global initiative; be responsible for working with external Agencies and leading a project team in it. The geographical coverage includes Russia and CIS, the position will be based in Moscow, Russia. **Major Job Objectives with subtasks** 1. Drive registration projects in accordance with defined strategic plan to contribute in business growth in 2025 and beyond It will be achieved through: ü Build and execution registration strategy for new molecular platform and reagents, mapping project implementation including instrument and samples availability, placement in the market, trials preparation, benchmarks to follow up with protocols and dossiers for submission in CIS + Manage project budget and resources to execute strategies designed to achieve a return on investment to the business + Be an expert in registration dossier and all related documentation preparation in line with strategic plan and changing local regulations. Deep understanding 11N rules, New coming rules for Russia and EAC registration process including timeline and costs ü Monitor and timely reflect the risks of MOH local legislation and regulatory normative changes. Prepare and run the actions to address + Work individually as well as forming a coherent team of regulatory specialists of the Agency with dedication for performance, strong commitment on projects to complete on time and aligned with agreed Key Performance Indicators ü Become main contact for Global Regulatory, AQR team to promote awareness of regulatory and customer requirements throughout the organization ü Keep internal tracking, retention and audit accessibility of registration documents, reflect internal changes, notifications monitor in accordance with AQR requirements ü Become a support with regulatory documents review prepared for registration purpose to other commercial teams in EME region. It will be done on request 2. Act as an industry regulation and product expert, being able to present company products and solutions It will be achieved through: + Become familiar with products portfolio, PCR and FISH molecular methods + Become main contact for local regulators including institutions, opinion leaders, relevant Agencies, labs, and clinical sites involved in the process.Represent AMD in regulatory events enhancing the Company's and AMD image in the medical community + Play an active role to notify the team, partners, regulatory body and other market participants regarding AMD products modification and changes + Ensure all products provided to the market packed, contain latest approved IFU and labelled in accordance with local legislation requirement ü Become familiar with IVDR requirements to provide necessary feedback and guidance to the EME team 3. Work closely with the regional team (commercial, admin/quality, application specialist and service team) contributing on a harmonized regional approach It will be achieved through: + Run regular registration status review with the team and regional management, ensure registration plan commitment and focus for the year and subsequent period + Ensure certificates needed access for commercial team, provide notifications timely and clarification letters on business request + Ad-promo material review and approval **Qualifications, Critical Skills and Experience** · Working knowledge and familiarity with medical device industry regulatory policies and procedures latest changes including EAC + Familiar with Quality and Quality Management systems (ISO 13485, ISO 9001 and US FDA QSR) · Documented record of delivering regulatory related information from the market which adds value to management's decision-making process. Maintain the highest levels of confidentiality internally and externally · Proved working relationships with local regulatory body, labs accredited for trials, related agencies, KOLs, and other regulatory stakeholders · Result oriented individual with ability to meet short and mid-term objectives · Evidence indicates person was in the top, handled big stretch roles with proved successful registration completion record · Set standards sought out and recognized leader with ability to persuade, motivate, coach and lead a team of regulatory specialists · Proved ability in complex projects handling, takes initiative to do more, faster & better · Eager to learn, constantly focus on self-improvement and self-development · Strong organizational and follow-up skills, as well as attention to details · Demonstrated verbal and written communication, negotiation, sales, interpersonal and presentation skills (Fluency in both English and Russian) · Ability to work in a highly matrixed and geographically diverse business environment · Ability to work as a team leader, within a team and as an individual contributor · High sense of urgency · Ability to multitask, prioritize and meet deadlines in a timely manner · High standards of ethics and compliance · High degree level (Molecular, Life Science, Medical are preferable) · Mature personality with a minimum of 4-5 years of experience in relevant RA roles and leader/senior level position in healthcare industry with documented success An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com