Regulatory Affairs Specialist II

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Petaling Jaya, Selangor, Malaysia

Job Description:

The Regulatory Affairs Specialist II MD is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices products under their responsibility.

The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions.

Key Responsibilities:


* The Regulatory Affairs Specialist will be a member of the local Regulatory Affairs department within Johnson & Johnson Sdn Bhd, Malaysia, with responsibility for regulatory aspects of the assigned product portfolio/s or Projects.


* Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans.


* Maintain departmental and source company databases of regulatory approvals.

Labelling and promotional material review as required.


* Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Malaysia and request the documentation required for registration submissions.


* Build constructive relationships with the local health authority by compiling and submitting required documents and providing prompt responses to questions.


* Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio.


* Participate in discussion groups for the industry association or discussion with HA, as required.


* Contribute to continuous review and improvement of processes within the Malaysia Regulatory Affairs department to ensure consistent, efficient and effective practices across the team.


* Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice.

Assist Regulatory Affairs colleagues in supporting other product portfolios or regulatory activities, as required.


* Engage marketing to strategize new product regulatory pathways or discontinuation.


* Support internal and external audits.