Regulatory Affairs Director Russia & CIS Job

Job description

Regulatory Affairs Director Russia & CIS-0000118EDescriptionOur Medical Devices and Diagnostics business segment produces a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopaedics, neurological disease, vision care, diabetes care, infection prevention, diagnostics, cardiovascular disease, and aesthetics is looking for a Regulatory Affairs Manager for Global Orthopedics.
Scope of the job
- Manages the registrations and re-registrations of the GO product portfolio
- Performs impact assessments of regulatory changes (products, labeling, environmental..) on products, business and licenses and for patients and HCP.
- Works with RA team members (Franchise and Regions), commercial partners, Governmental Affairs and Policy, Legal Affairs, EHS to oversee the regulatory aspects for (pro-active) involvement
- Ensures product compliance for the Russian Market
- Managing the registrations and re-registrations
- Monitoring of Russian local Regulatory Environment and feed-back to relevant stakeholders
- Coordination of the deployment of J&J standard requirements as e.g. copy review, J&J RA standard
- Ensuring product compliance for the Russian market, this includes but is not limited to: copy review, product labeling, environmental legislations, advertisement and promotionsClose interface with following stakeholders:1. Marketing and sales organization2. International and Regional/national Regulatory Affairs Departments3. J&J Medical/Regulatory Affairs Organization4. Quality Regulatory complianceQualificationsAttorney with 5 orHigh degree of initiative.
- Team player, fosters the strength of a network
- Communication and negotiation skills.
- Open minded, listens to others
- Customer focused
- Able to manage complexity and Matrix organization
- At ease in International environment.
- Fluent in English
- Well organized, sense for detail
- Diplomacy
- Degree of Pharmacist or Scientific Degree or Law Degree
- Knowledge of National regulations and standards
- Knowledge of ISO 9001:2000 Standard and ISO 13485 standard
- 4-5 years working in Pharmaceutical and/or Medical Devices CompanyPrimary Location:Europe/Middle East/Africa-Russia-Moscow-MoscowOrganization: J&J LLC Russia (8431)Job Function: Regulatory Affairs