The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Pharmaceuticals, Quality/Risk Management, Worldwide Regulatory Affairs
4 Year Degree
Oasis Medical Inc. provides a collaborative working environment with values that encourage employees to expand their talents, while contributing to the growth of the Company. Oasis is a manufacturer of medical devices and pharmaceutical products for Ophthalmology and Optometry, where we offer products for the Surgical and Dry Eye markets. Oasis creates a quality eye care experience through our solution-based products, that result in long-term relationships with Practices. Our culture is committed to Accountability and our Professionalism is demonstrated by our Truth based approach to business.
The Regulatory Affairs Specialist provides administrative and technical support to ensurecompliance with all FDA and other U.S. and international regulatory requirements. The position establishes and meets timelines and corporate objectives to ensure timely approvals. The position performs a vital part in enhancing the company’s infrastructure, and has the capability to contribute to the strength and sustainable growth of Oasis Medical.
Essential Job Functions
Maintain and update Technical Files/Technical Documentation for existing CE-marked products and assemble new Technical Documentation in compliance with the European MDD 93/42/EEC and MDR 2017/745
Support and prepare new product submissions in the US, Canada, and EU
Establish timelines, follow-up, facilitate cross-functional team meetings relevant to the regulatory processes, and ensures timely execution
Provide support to currently marketed products as necessary. This includes reviewing labeling, marketing material, product changes, significance determination of changes, and documentation or change notifications/license amendments for changes requiring regulatory approval
Develop, prepare, and submit technical and regulatory documents for international product registrations
Ensure compliance to domestic and international regulations and standards
Work with and respond to inquiries and audit findings from the FDA, notified bodies, and international regulatory agencies
Collaborate with Sales and Marketing personnel to identify regulatory requirements for international product registrations
Request FDA Certificate to Foreign Government and Certificate of Exportability as needed
Support Quality Assurance in developing and executing compliance activities and corrective actions involving regulatory authorities
Process document legalization, authentication, and apostille as needed
Provide support, prepare, and review quality and regulatory documents (operational procedures, Risk Management Documents, Clinical Evaluation Reports (CERs), and Post-Market Surveillance (PMS) related plans and reports) and memorandums
Maintain and update Establishment Registrations, Device and Drug Listings and State Licenses
Maintain and update master lists of international standards, regulations, guidances, and approved products per country
Identify change and improvement in work processes to promote efficiency as OASIS grows
Adhere to general safety rules, manufacturing procedures, quality procedures, and company policies as applicable
Exhibit professional behavior and demeanor at all times; proactively resolve issues using Best Practices
Perform other duties and responsibilities as requested or assigned
Minimum B.S. in scientific field, preferably life sciences, engineering, and/or regulatory affairs; Graduate degree is preferred
2+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with B.S. degree
1+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Master’s degree
Knowledge of US and international regulatory requirements, including Quality Management System, GMPs, design control, medical device submissions requirements, labeling and marketing regulations, auditing principles
Experience with maintaining ongoing compliance in a regulated environment, organizing and maintaining detailed regulatory and quality records and documentation.
We ask the candidate to be willing to release an Old Model analytic approach to consider a New Mindful strategic approach. The Candidate will join a group of authentic and talented professionals with the ability to listen, ask relevant questions, and create wins for all parties. Each hand-selected team member understands how to get out of their own way, and is committed to growth and Continuous Improvement. Free of ego and drama, this Quality Coordinatorposition includes:
A Strategic Approach to be immersed in the detail, while maintaining a perspective of the Bigger Picture
The ability to communicate respectfully with co-workers and generate goodwill and confidence within the team
Leads with Discernment and Impeccable integrity that honors Confidentiality
Holds a Genuine concern for the Company’s well being
Commitment to an Introspective journey at a Continuous Improvement Company, understanding that our Mindset can reflect in our interpretation and therefore our recommendations
Ability to work well individually and as a team member, demonstrated by a collaborative team orientation and an apolitical style
Internal Number: 01
About OASIS Medical, Inc.
OASIS® Medical, Inc., is dedicated to equipping eye care providers with cost-effective solutions to ensure quality patient care, improve practice management, and support practice growth. OASIS supplies high-quality surgical and dry eye products to eye care professionals that provide solutions to chronic conditions and make a meaningful difference in patients' quality of life.
OASIS is a continuous improvement company deeply committed to truth in its business approach, relationships, and products based on our foundation of accountability. We welcome feedback from customers and our team to evolve as a pro-active company.