Regulatory Affairs Specialist

Select how often (in days) to receive an alert:

he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and applicable regulatory requirements. This position will also prepare, monitor, and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, change analysis, claims review, and vigilance reporting. This position is also responsible for design control compliance for assigned products and will support development and execution of regulatory strategies per timelines to ensure clearance / approval in the assigned geographies.

• Support compilation of high-quality regulatory submissions for all products to expedite clearance/approval and sustain commercial availability for all products and support interactions with regulatory agencies.
• Participate on development project teams providing the team with information on applicable regulatory requirements.
• Support compilation of technical documentation to support CE-marking for assigned products.
• Support registration outside EU with appropriate documentation and maintain regulatory registrations and licenses.
• Review and approve change controls, supplier evaluations, and non-conforming material reports for potential impact on regulatory status. Prepare submissions, supplements, amendments, and letters to file as needed to document rationale. Keep design history file (DHF) current.
• Review and approve IFU, labels and promotion material
• Work with Clinical and Quality to prepare post-market data for inclusion in periodic reports required by regulation and other post-market surveillance activities as needed.
• Participate in CAPA investigations, root cause analyses, corrective actions, and verification of effectiveness.
• Coordinate and document recalls or other RA related field actions. Report and update appropriate regulatory bodies as needed.
• Participate in notified body, FDA, and internal audits, including audit responses.
• Review complaints identified as potentially reportable to authorities and report or document a rationale for not reporting within the required time windows.
• Analyze, summarize, prepare, and present data for Management Review meetings.
• Maintain RA processes, procedures, and instructions to stay current with changing requirements.
• BA/BS Degree or equivalent experience, scientific field degrees preferred
• 3+ years’ experience in regulatory affairs in Medical Device industry
• Familiarity with FDA and EU regulations for medical devices. Prefer candidates with CE marking and Health Canada experience
• Experience with FDA interactions/presentations preferred
• Experience with recalls, adverse event reporting, biocompatibility, claims review, and post-market surveillance desirable

• Quality mindset-Right the First Time Focus
• Able to work well in cross-functional teams, independent yet a team player
• Demonstrates a continuous desire to understand, learn and implement up-to-date regulatory requirements, best practices and trends
• Analytical and able to work with complex data while still seeing the big picture
• Excellent oral and written communication skills with the ability to listen, articulate, facilitate, and advocate
• Maintains an extremely high attention to detail and follow through
• Effective Organizational skills
• Demonstrates both creative and critical thinking skills
• Proficiency in Microsoft Office including Outlook, PowerPoint, Word, and Excel
• Pro-active; high-performance and results orientation
• Ability to consistently work, manage, and lead with ethical integrity
• Open-minded with a global mindset
• Embraces cultural differences within a global organization
• Agi…