As Vyaire strives for continuous improvement and future growth, it seeks an experienced, passionate, and dynamic Director to lead all aspects of Regulatory Compliance for the company. Based out of Irvine, CA this role will report to the Vice-President of R&D, and will work closely with R&D, Quality, and RA teams with focus on updating the Technical Files of existing products per Medical Device Regulations (MDR). This position will lead a cross-functional team in conducting the assessment and executing the identified actions to fulfill the applicable compliance requirements and standards globally. The Director of Regulatory Compliance will serve as the subject matter expert of the evolving global regulations through the total product life-cycle.
In particular, you can expect to:
- Form a cross-functional team from R&D, Quality, Supply Chain, and RA and conduct in-depth systematic assessment of Technical Files for legacy products per applicable requirements.
- Develop a multi-years project plan in fulfill the MDR requirements and provide initial training to stakeholders.
- Work with Sr. Management team and develop the resource requirements with target timelines.
- Effectively partner with the R&D Engineering and identify the required testing and data per MDR essential requirements.
- Proactively identify the applicable product specific standards to ensure products meet the most current version of standards.
- Work closely with Supply Chain for Suppliers and OEM partners to enhance the regulatory compliance.
- Partner with Facility to ensure product fulfill the applicable environmental related requirements such as GHS, RoHS, REACH, CA Prop 65 and others as required.
- Guide Clinical team to ensure maintenance of the Clinical Evidence Report (CER) per applicable requirements.
- Coordinate with Quality Systems and Compliance teams to ensure efficient compliance toward applicable Standards and Regulations.
- Formulate Regulatory strategies to expedite licensing and registration of Vyaire products both domestically and internationally, as needed.
- Work closely with R&D Engineers for product development and design changes. This includes serving as SME and counseling R&D project team leaders as to product design, and required field and in-house studies to support regulatory strategies.
- Develop RA professionals and the RA competency of Vyaire.
- Interface with government authorities for the discussion of adverse events, general questions, or the approval of products.
- Monitor the activities of government regulatory authorities on a worldwide basis to ensure that the business is able to align with, comply with, and anticipate changes.
- Develop a strong working relationship with internal partners to ensure compliance with regulatory requirements and provide appropriate support across the business.
- Prepare, present, defend, and manage the RA Compliance departmental budget and staff.
You will have the opportunity to:
- Improve patient outcomes
- Meaningfully impact the company?s short-term and long-term success
- Work closely with executives across the organization
- Grow your role as you see fit
- Learn about respiratory medical device manufacturing
- Create an inspiring and productive workplace
To be successful, you will need:
- A minimum of 10 years of related experience in the medical device and/or medical diagnostics industry, with at least 4 years of management experience.
- Be a high energy, results-oriented leader with excellent collaboration and project management skills.
- Detail oriented with excellent organizational skills; multi-tasking capability is required.
- Have a track records of effective preparation of Technical Files per MDD requirements.
- Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements (e.g. FDA QSR and ISO/EN standards).
- Experience preparing, submitting, and managing multiple FDA and other Regulatory Submissions (510(k), PMA, etc.).
- Effectively interface with the Supply Chain, Quality Assurance and R&D partners.
- Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies.
- Bachelor of Science degree engineering or a scientific or technical discipline.
- Master of Science degree engineering or a scientific or technical discipline preferred.
- Regulatory Affairs Certification (RAC) is preferred.
- Excellent verbal and written communication is required.
- Based in Yorba Linda/Irvine, CA .
- Travelrequired up to 20%, including international.