Johnson & Johnson Careers
Regulatory Affairs Specialist
Requisition ID: 1905774888W
The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
Regulatory Affairs Specialist, Region Central CEE
Location: Prague, Czech Republic
Full time contract
In this position, Regulatory Affairs Specialist will be responsible for the effective maintenance of compliance programs in accordance with applicable European and National Regulations.
The role will assure timely medical device notification / registrations in accordance with European and National Legislation in the CEE central region and all tasks connected with. Provide support in RA matters to ensure compliance and business continuity.
YOUR responsibilities & YOUR impact:
- Ensures regulatory clearance of medical devices (eventually biocides, VET products) being in product portfolio of J&J MD, within timelines. Responsible for coordination and preparation of regulatory product notifications, submissions and strategies. Manage the final product submissions, negotiate and communicate effectively with regulatory authorities and where appropriate Distributors.
- Maintaining local and global regulatory document database.
- Deliver RA trainings to local organizations and distributors where appropriate.
- Provide Regulatory support to Tender Management, Health Economics & Reimbursement, Business, Distributors and Franchises.
- Ensure company complies with environmental regulation (e.g. WEEE, REACH), contact person to Environmental Authorities, and submit environmental reports, where appropriate.
- Provide routine communication and updates to site and organizational management regarding regulatory compliance and regulatory affairs.
- Responsible for Copy Review of J&J MD.
- Establish local and regional relationships with business partners and internal/external RA groups (MD) Franchise and DC.
- Provide feedback on problems related to regulatory compliance.
- Lead projects related to Regulatory Affairs compliance, where appropriate.
- Provide support to remove regulatory restrictions in Distribution Center.
- Ensure compliance of labelling with local regulatory requirements
- Keep regulatory SOPs updated and followed
- Support deployment of JnJ Standards into LOC QMS related to Regulatory Affairs aspects.
- Interfacing with other departments to coordinate the development of regulatory procedures, documents and controls to ensure compliance in a timely manner. Review and disposition document changes within areas of expertise per applicable procedures.
We would love to hear from YOU, if you have:
- Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.
- At least 2 year experience in MD Regulatory Affairs environment.
- Excellent interpersonal skills - build and maintain excellent relationships with internal and external partners.
- Precise planning and execution to achieve accurate and timely results.
- Sense of importance and mission of the role.
- Advanced knowledge of Microsoft Word, Excel and related functions.
- Excellent organizational skills and attention to detail.
- Excellent communication skills – both written and oral, and the ability to liaise with internal and external parties.
- Excellent English and Czech.
- Ability to understand cross-enterprise data flow and system.
- Embodies values, ethic and trust.
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees benefits.
Johnson & Johnson, s.r.o. (7065)