Katalyst CRO ยท 3 months ago
Regulatory Affairs Manager
Raleigh, NC
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a leading organization in the medical technology sector, and they are seeking a Regulatory Affairs Manager to lead regulatory strategies and product submissions. This role involves overseeing a team of regulatory professionals to ensure compliance and facilitate timely product approvals across various international markets.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more
Work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions
Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management
Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies
Oversee and coach a team of regulatory professionals to support both strategic and operational objectives
Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.)
Define and execute submission strategies to meet timelines and business goals
Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review
Monitor changes in international regulatory environments and communicate impacts to internal teams
Represent the company in industry groups or regulatory associations, where appropriate
Support training and knowledge-sharing on country-specific regulatory requirements within the organization
Qualification
Required
Bachelor's degree and/or master's in biology chemistry bio-engineering or related scientific area
5 years of medical device IVD Regulatory Affairs experience to include either 510(k) or PMA Notified Body (NB) submissions
Proficient in the aspects of regulatory strategy creation design control cGMP/Quality Systems and import/export requirements
Experience in direct communication with regulatory agencies
Regulatory review experience of promotional marketing materials presses releases labelling etc
Strong oral and written communication skills as well as the ability to provide scientific presentations
Ability to compile data and summarize results
Continuous improvement minded familiar with balancing Quality and the need for efficiency
Preferred
Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase