Senior Regulatory Affairs Specialist

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types.
• Working under general supervision, they contribute to complex strategies, support audits, and guide junior team members.
• The role also manages change activities for sustaining products, ensuring regulatory partners are informed of key updates.
• Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provides regulatory guidance to the project teams.
• Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies.
• Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
• Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
• Maintain regulatory documentations to support compliance with regulatory requirements.
• Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
• For our office-based teams, this means working in-person at least 3 days per week.
• Onsite roles require full-time presence in the company's facilities.
• Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

Requirements:

• You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field.
• Experience authoring US 510k and EU MDR Tech Files required.
• Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's.
• You have a bachelor's degree or higher in a related field.
• This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

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