Regulatory Specialist

Job Description Overall purpose of job:  

In this position, Regulatory Affairs Specialist will be responsible for regulatory compliance of medical devices distributed on CEE Central Region market - notifications of medical devices and all tasks connected with, system updates and review of copy review materials. RA Specialist will provide support in RA matters to ensure compliance and business continuity.  

Key responsibilities:  

Ensure regulatory clearance of medical devices being in product portfolio of MDs within timelines. Coordination and preparation of product notifications. Managing product submissions.  

Responsible for updates and approvals in systems linked to job duties and maintaining RA databases.  

Review of copy review materials for CEE Central region.  

Provide regulatory support to relevant teams and partners - Tender, Health Economics & Reimbursement, Business, Distributors and Franchises and deliver RA trainings to local clusters.  

Provide communication and updates to management regarding regulatory affairs.  

Ensure timely communication and feedback on problems and events related to RA compliance.  

Collaboration in process of RA restrictions removal.  

Establish and keep relationships with business partners and internal/external RA groups (MD) Franchise and DC.  

Monitor legislative situation, lead projects related to compliance and ensure that RA SOPs are updated and followed.  

Provide support during internal and external audits.  

Support deployment of DS Standards into LOC QMS related to RA aspects.  

Collaborating with various departments to coordinate development of procedures, documents and controls to ensure compliance in a timely manner. Review and disposition document changes within areas of expertise per applicable procedures.  

Perform other work-related duties as assigned by manager.  

Required Qualification and Core Competencies for the role:  

Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.  

At least 2 years of experience in Regulatory Affairs environment.  

Excellent interpersonal skills - build and maintain relationships with internal and external partners.  

Detailed 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 collaborate closely with internal and external parties.  

Languages: Polish and English required, additional CEE languages beneficial  

Ability to understand cross-enterprise data flow and system.  

The embodies values, ethic and trust.  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

 Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. 

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