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Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

Katalyst Healthcares & Life Sciences

Alpharetta, GA

Other

Posted 26 days ago

Job description

Responsibilities:
  • This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
  • Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
  • Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
  • Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
  • Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
  • Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
  • Submit notifications to the EU Notified Body for significant changes to CE marked products.
  • Maintain Regulatory documentation.
  • Support special projects, as needed.
Requirements:
  • B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry.
  • 2-5 years Medical Device experience.
  • Working knowledge of industry consensus standards and FDA guidance is required.
  • At least 2 years Regulatory Affairs experience in Medical Device regulations.
  • Demonstrated success in taking products through FDA and EU Notified Bodies.
  • Working knowledge of 510(k), MDD 93/42/EEC.
  • Regulatory Affairs Certified RAC (RAPS).
  • Proficient in using Microsoft Office.
  • Strong communication and project management skills.
  • Must be able to handle multiple tasks.
  • Attention to detail.
  • 510(k), MDR.
  • 21 CFR 820 - Quality System Regulation, ISO 13485.
  • Medical device standards and FDA guidance relevant to medical devices.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Regulatory Affairs Specialist?

A: To succeed as a Regulatory Affairs Specialist, key technical skills include in-depth knowledge of regulatory frameworks, such as FDA and EU regulations, as well as proficiency in regulatory documentation, including submissions and compliance reports. Soft skills like strong communication, negotiation, and problem-solving abilities are also crucial, as Regulatory Affairs Specialists must effectively collaborate with cross-functional teams, stakeholders, and regulatory agencies to ensure compliance and product approvals. These technical and soft skills enable Regulatory Affairs Specialists to navigate complex regulatory landscapes, drive product approvals, and contribute to the overall success of their organizations.

Q: What is the career path for a Regulatory Affairs Specialist?

A: A Regulatory Affairs Specialist's career path typically begins with entry-level roles such as Regulatory Coordinator or Compliance Assistant, where they assist in preparing and submitting regulatory documents, and learning about industry regulations. As they gain experience, they progress to mid-level roles like Regulatory Specialist or Senior Regulatory Coordinator, where they take on more responsibility for regulatory submissions, compliance, and stakeholder engagement. Senior roles, such as Regulatory Affairs Manager or Director of Regulatory Affairs, involve strategic planning, leadership, and oversight of regulatory teams, and often require advanced degrees and specialized certifications like the Certified Regulatory Affairs Professional (CRCP) or the Regulatory Affairs Certification (RAC).

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Katalyst Healthcares & Life Sciences job posting for a Regulatory Affairs Specialist II in Alpharetta, GA with a salary of $70,800 to $106,500 Annually with a map of Alpharetta location.