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Regulatory Affairs Specialist

  • Permanent
  • Anywhere

Website Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : South Plainfield, New Jersey

Post: Fri, 09 Sep 2022 15:31:09 GMT

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

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Assists the Regulatory Affairs Team for ensuring compliance with the requirements set by the EU Medical Device Regulation and other regulatory bodies for Medical devices registration across different geographies.

Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia.

Prepare and review the documentation required for Change submission, Notification , Re-registration of Medical devices

Provide guidance to the offshore team in the preparation of documents for change submission, notification, re-registration packages of Medical Devices for regulatory agencies submission.

Understands existing technical files / design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and prepare the Country specific STEDs.

Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo RAs

Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.

Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.

Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information.

Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.

Maintains information systems (electronic and paper) for regulatory information and reports.

Oversee and ensure maintenance of regulatory licenses renewals on timely manner

Clearly conveys information to peers, supervisors and other stakeholders

Supports the development of internal RA systems and procedures.

Maintains SOPs related to RA activity and suggests update of the QMS

Requirements:

Regulatory knowledge (European Medical device directive and Medical device Regulation,

Bachelor / Master of science in Biomedical Engineering/ Bioengineering discipline

Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820)

Regulatory experience and Project Management experience, registration and submissions experience from medical device industry.

Very good written and oral communication in English.

Ease for reading/creating/modifying documents.

Able to work with minimal supervision. Self-motivated team player.

Knowledge in geography specific regulatory requirements for medical devices (APAC, LATAM, EMEA, Canada, China, Russia.)

Experience in Class III implants

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