OmegaQuant Analytics (OQA) is a leading global, independent, CLIA-certified clinical laboratory that offers human nutritional testing to researchers, healthcare providers and the public. The “Omega-3 Index” was invented by the founder of OQA, Dr. Bill Harris, and is our flagship test. OQA as the 2010 winner of the Giant Vision Award, which recognizes the best new business in South Dakota and was ranked #2271 on the Inc 5000 List of fastest growing private companies in 2019.
Due to rapid growth and expansion, we have an exciting opportunity for a quality and regulatory specialist to join our team in Sioux Falls, South Dakota. The Specialist’s role involves working cross functionally with management, science, laboratory, quality, engineering and consultants during the design process, test development, jurisdiction expansion and product lifecycle. This involves a broad range of activities including QMS development and implementation, regulatory submissions to the relevant authorities, marketing authorization and submissions, participating in certification inspections, vigilance and adverse event reporting and clinical evaluation in the In-Vitro Diagnostics/Medical Device environment.
The primary function of this role is to support the quality and regulatory affairs requirements in the global jurisdictions in which OmegaQuant operates to ensure that they are managed in a smooth and efficient manner. Would also be responsible for global regulation, managing pre- & post- market regulation for all product classifications and devices across Europe, USA, Australia and other regions as we expand.
The position may require some travel from time to time.
What you will do:
This role involves:
- Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of quality and regulatory affairs.
- Development of Quality Management System (QMS), implementing compliance procedures for staff to follow and maintenance of the QMS thereafter.
- Ability to manage team regarding customer complaints, document control and training practices.
- Lead audits and inspection preparations.
- Prepare and manage medical device registrations for approval by the US Food & Drug Administration, EU Competent Authorities, certification/notified bodies and other authorities.
- Liaise with the regulatory officials and consultants on product classifications; De Novo and 510k Applications.
- Liaise with competent authorities on device listing, establishment registrations, adverse event reporting and substantial changes.
- Be the Regulatory Affairs subject matter expert for Notified Body and other regulatory audits
- Work closely with the laboratory and laboratory partners to ensure regulatory requirements are continually met for test method qualifications/clinical studies/LDTs
- Work in the areas of Vigilance, Post Market Surveillance and periodic safety update reports
- Contribute towards the development of the Regulatory Strategy
- Keep up to-date with US, EU and other global regulatory guidelines
- Build and maintain strong relationships with Regulatory Authorities, Consultants, CROs and internal departments
- Participate in Continuous Improvement Initiatives to further develop department functions.
- Act as responsible Regulatory Team member for assigned regulatory projects
- Actively participates in meetings with customers for regulatory and quality
- Understand the Scope of Work, timelines and deliverables for a given project.
- Prepare status reports and metrics for assigned projects
- Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
- Any other duties as assigned by your Manager
What we are looking for:
Our most ideal candidate is someone who has a passion for health, quality and regulatory and is organized, works independently and has attention to detail. To be considered for this position, you will need to have at least 2-4 years in regulatory and/or quality experience with working knowledge of ISO:13485, CLIA, CAP, ISO:17025, and ISO:15189.
To be successful in this role, you will need:
- Preferred Life sciences degree (BSc or equivalent).
- 2-4 years regulatory and/or quality experience
- Work independently with minimal supervision
- Hardworking, self-motivated and with attention to detail
- Excellent working knowledge of the USA and EU regulatory requirements and procedures required.
- Working knowledge of requirements for ISO:13485, CLIA, CAP, ISO:17025, and ISO:15189 or ability to learn.
- Familiarity with electronic submissions (eCTD) useful but not a requirement.
- Candidates must be familiar with MS Office, or equivalent, etc.
- Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage.
- Preparation of relevant technical, safety and performance technical documents to support submissions, in collaboration with colleagues
- Experience of emerging markets / international RoW markets and regulatory filings
- Quality control review of technical/ regulatory documents
- Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
- Compliance with SOPs, Change controls and regulatory best practices
- Project management experience – an advantage
Joining the OmegaQuant Team
An attractive salary package with possible bonuses available on completion of a clinically useful test. Other benefits include:
- Paid Time Off and holidays
- Medical, Dental, Vision insurance offered
- 401K with employer match
- Tuition reimbursement
- Wellness program and reimbursement
- Opportunity for growth and advancement
To apply for this role, please email your resume and cover letter to firstname.lastname@example.org.