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Regulatory Affairs Specialist

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

5+ years Regulatory experience in medical devices, Familiarity with international regulations.

Key responsabilities:

Prepare and submit documentation for global regulatory registration
Collaborate with cross-functional teams for product release
Act as regulatory advisor on product development teams
Maintain knowledge of domestic and international regulations
Review and ensure compliance of product changes

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry of instrument hardware and software.
Experience working of outside US Registrations OUS experience preferred.
Understanding of International Regulatory submissions.
Interface directly with FDA and other regulatory agencies.
Work with cross-functional team to support product release process.
Conduct reviews of product and manufacturing changes of instrument hardware and software for compliance with applicable regulations.
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
May interface directly with FDA and other regulatory agencies.
Work with cross-functional team to support product release process.
Review protocols and reports to support regulatory submissions.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements:

5+ years of Regulatory experience in a medical device industry
Experience with pre-submissions, 510k submissions, Instrument/Software Submission experience, Design Planning, On-Market Changes, Post Market Assessments, and FUE Changes
Experience working in a broader enterprise/cross-division business unit model