Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences
Canton, MA 02021
About the Job
Responsibilities:
- Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
- Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.
- Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies.
- Prepares and submits US 510(k) submissions.
- Identifies and communicates potential risks and mitigations associated with reg. strategies.
- Coordinates interactions/negotiations with U.S. regulatory agencies.
- Participates in internal/external trade, professional, and standards development organizations.
- Reviews and approves labels, labelling, and promotional materials.
- Review's product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
- Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
- Monitors worldwide regulatory developments (standards, guidance documents) and communicates emerging opportunities/concerns impacting BU products.
- Act as Global Business to Business RA Lead supporting pharmaceutical customer regulatory activities (i.e., Combination Device Submissions, Letter of Authorization Request, Product Registration Status).
- Carry out the above tasks without supervision.
- Ability to read, analyse, and interpret regulatory literature and documents.
- Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
- Strong communication (written, oral) and project management skills.
- Able to handle multiple competing tasks with attention to detail.
- Strong critical thinking skills.
- Able to work independently to achieve objectives on or before schedule.
- Demonstrated global perspective, customer-cantered, cross-functional collaboration, and partnership skills.
- Extensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
Source : Katalyst Healthcares & Life Sciences