Katalyst CRO ยท 5 hours ago
Regulatory Affairs Manager
Charlotte, NC
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on regulatory affairs in the biotechnology sector. They are seeking a Regulatory Affairs Manager to provide guidance on regulatory submissions and lead project teams in compliance with regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals
Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements
In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed
Document regulatory strategies for product submissions
Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
Facilitate FDA pre-submission meetings
Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
Support EU representatives in their creation of CE/IVD Technical Files
Support global regulatory registration representatives for product registration activities
Perform regulatory assessment of new and changed products
Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc
Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment
Participate in business meetings with potential new external partners
Assist the Regulatory department in updating, improving, and crafting internal policies and procedures
Qualification
Required
B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experience
Hands-on experience with 510(k), PMA, and PMA supplement submissions
Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
Ability to lead multiple projects and meet deadlines
Strong communication and teamwork skills
Capacity to communicate regulations to technical functions within the company
Experience as the RA representative on project core teams
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 (28)
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
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