Seegene USA
About this role:
The Regulatory Affairs Manager is responsible for the preparation and support of pre-submissions and 510(k) regulatory submissions and product registrations required to market in vitro diagnostic (IVD) devices in the United States. They will serve as the strategic project regulatory leader to provide strategic and tactical support with cross-functional development teams. They will act as a steward for Regulatory Affairs and have the opportunity to work with a team of professionals while collaborating with external company leaders to support the Company’s mission. They will work closely with our Chief Medical Officer to establish and execute clinical study protocols in support of the Company’s regulatory strategies.
What we offer:
- Join the fast-growing team with all the opportunities to build together
- Amazing team to work with
- Seegene pays 100% of Health insurance/Life/STD/LTD premium for the employee and 70% for dependents. Other voluntary insurance is also available.
- Generous 401k, no vesting period, no waiting period
- Generous vacation and corporate holidays
- Various employee discounts and perks
Job Responsibilities:
- Lead and manage all aspects of preparing and filing regulatory submissions (class II and III 510(k), de novo 510(k) and PMA) and obtain required regulatory clearances/approvals.
- Conduct regulatory analysis and propose regulatory strategies for the Company’s IVD products.
- Authors, reviews, and/or approves technical protocols and data in support of clinical trials, validation, verification, and product manufacturing for pre-market submissions.
- Author, review and/or approve product labeling to ensure compliance with regulatory requirements.
- Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU), to ensure adherence to applicable regulations and standards.
- Assists in management of third party and internal audits.
- Review promotional and advertising materials to ensure regulatory compliance.
- Research and interpret regulatory requirements and effectively communicate requirements to the Company’s stakeholders.
- Write and update QMS documents required for regulatory compliance and to meet regulatory requirements.
- Stay current on regulatory requirements related to the Company’s products.
- Serve on Core Teams and Develop overall timelines and plans by working with team members in research and development, QA, manufacturing, etc., to ensure regulatory requirements are properly addressed and followed throughout product development lifecycle.
Minimum/Required Qualifications
- Requires a B.S or higher degree in Biology related disciplines.
- Requires minimum 5 years of regulatory experience in an IVD manufacturing environment.
- Requires a proven track record of successfully obtaining 510(k) clearance or PMA approval on at least three (3) IVD products.
- Requires expertise in molecular diagnostics, specifically PCR assays.
- Extensive knowledge of infectious disease and oncology IVDs.
- Must have strong organizational skills, detail orientation, strong leadership, and critical thinking skills.
- Must be able to work in a fast-paced environment, multi-task, and have good communication skills, both verbally and in writing.
Additional/Preferred Qualifications
- Strong results orientation and effective change agent
- Knowledge of Quality Assurance and Regulatory Affairs principles
- Expertise in relevant regulations and standards, including 21 CFR 820, 21 CFR 58, ISO 14971, ISO13485, and ISO9001.
- Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.
- Skills in troubleshooting and critical thinking.
- Ability to build strong relationships across a wide spectrum of internal and external parties.
- Ability to act independently on routine assignments or projects.
- Ability to plan, organize, and multi-task to complete assignments in an efficient manner.
- Ability to communicate professionally, both oral and written.
- Ability to pay attention to details and perform at a high level of accuracy.
- Ability to work independently and with a team.
Desirable Characteristics/Attributes
- M.S. or Ph.D. in biological sciences
- Successful experience collaborating with global regulatory teams
- Oral and written fluency in Korean
You can apply for this position via LinkedIn using the button below or by completing the application form at the bottom of this page.
