Regulatory Specialist

jj

Warszawa

On-site

PLN 146,000 - 235,000

Full time

7 days ago

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Benefits offered by this job

annual bonus

vacation days

parental leave

bereavement leave

caregiver leave

volunteer leave

well-being reimbursement

Job summary

Johnson & Johnson's DePuy Synthes division in Warsaw seeks a Regulatory Specialist to ensure regulatory compliance for medical devices in the CEE Central Region.

You will manage product notifications, submissions, and system updates, and work with cross-functional teams to support audits and the deployment of RA SOPs.

Requirements include 2+ years in Regulatory Affairs, fluent Polish and English, and strong communication skills.

Qualifications

Regulatory knowledge of medical devices and RA environment.
At least 2 years of experience in Regulatory Affairs.
Excellent interpersonal and communication skills.

Responsibilities

Ensure regulatory clearance of medical devices within timelines.
Coordinate and prepare product notifications.
Manage product submissions and RA databases.
Provide regulatory support to teams and partners.

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

DePuy Synthes is recruiting for a Regulatory Specialist located in Warsaw, Poland.

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.

The anticipated base pay range for this position is:

zł145,800.00 - zł234,600.00

Benefits:

annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health
service anniversary and recognition awards
employees - and in some location’s eligible dependents - can participate in several insurance plans

For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills: