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Regulatory Affairs Specialist 3

  • Permanent
  • Anywhere

Website Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Franklin Lakes, New Jersey

Post: Fri, 09 Sep 2022 03:29:24 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager

Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market

Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market

Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation

Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders

Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance

Identify ways to improve the efficiency of current work process and best practices as necessary.

Requirements:

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)

B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred.

Medical device and international registration experience is a must. Combination Products knowledge or experience is a plus.

Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint

Strong project management and communication (verbal, written) and skills

Able to independently handle multiple tasks/projects with minimum supervision

Self-starter with the ability to take over responsibilities

Team player, Attention to details, highly result-oriented

Flexible and reliable personality; ability to manage stressful situations

High personal integrity and ethical standards

Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)

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