DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. For more information, visit www.depuysynthes.com
The Manager is responsible for:
Setting the strategic direction and priorities for product registrations in Russian market.
Leading communication between Russia and Franchise RA teams, and expediting Russian registrations for high-priority projects.
Educating Franchise associates on Russian regulatory requirements and integrating these requirements into Franchise procedures.
Actively identifying and resolving complex issues associated with gaining and maintaining product approvals in Russia.
Partnering with Regulatory Policy team to monitor changes in regulations and expectations in key strategic markets and shaping future regulatory changes.
Exhibiting expertise in Russian regulations regarding design, development, manufacture and distribution of products.
Ensuring EURASIAN Union requirements are understood by Franchise and collaborating with the local regional team on the creation of a submission plan.
Position duties & responsibilities:
Setting Franchise strategy and prioritization for launching new products and maintaining market access in accordance with Russian requirements.
Partner with Regional RA Leads to assure compliant, timely submissions and approvals.
Lead implementation of new or amending Russian regulations to maintain market access.
Participate on new product development and lifecycle management teams as appropriate to provide regulatory expertise and direction for compliance to Russian requirements.
Monitoring complex issues related to the maintenance of global product registrations, and, when necessary, developing and leading remediation activities.
Review government, trade association, industry, medical and scientific publications to keep informed of, developments that may impact the regulatory status of products.
Address complicated issues that may affect submission status, advancing those issues that cannot be resolved locally.
Prepare submission status reports including metrics for review at meetings and by management.
Coach Franchise associates to increase understanding of Russian and EAEU requirements, and update Franchise procedures to maintain compliance.
A Bachelor's Degree or higher from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration is required (Master’s degree or higher is preferred).
Experience in Russian regulatory approvals of initial or modified medical devices is preferred.
8+ years of relevant experience conducting regulatory activities is required.
Excellent written and verbal communications skills is preferred.
Fluent in English language and Russian preferred.
Project Management experience is preferred.
Business presence and acumen is preferred.
Demonstrated leadership, organizational, and planning skills with the ability to work cross-functionally with a culturally-diverse work force and customer base.
A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously.
Ability and confidence to effect informed decisions based on US and Russian regulatory trends, government constraints and an understanding of business needs.
Analytical and process improvement skills.
Knowledge and deep understanding of how regulations impact product registration and market access.
Ability to travel may require up to 20% domestically and/or internationally.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.