SEKISUI Diagnostics is looking for a Principal Regulatory Affairs Specialist to join our team and help drive regulatory strategy and execution for our diagnostic solutions, to get them into the hands of healthcare professionals because we know that every result matters for the patients we support.
Who are you? You bring over 8 years of Regulatory Affairs experience—particularly in the realm of Point of Care and in vitro diagnostic (IVD) devices and instrumentation —and have a proven record of guiding successful FDA 510(k) submissions and CLIA Waiver applications. Your deep knowledge of U.S. FDA and IVDR regulations and current guidance for diagnostic devices enables you to develop effective regulatory strategies for new product introductions. You have a strong understanding of MDSAP principles and audit processes that allows you to be a key player in international product support. You excel at translating complex regulatory requirements into clear, actionable steps with your exceptional communication skills. In addition, your strong leadership and project management abilities allow you to independently drive initiatives forward, providing direction and clarity for cross-functional teams.
In this role, you will:
- Lead regulatory strategy for product development from concept through to clearance, including preparing and submitting high-quality 510(k) and CLIA Waiver applications to the FDA.
- Act as the regulatory lead on cross-functional product development teams, collaborating closely with R&D, Quality, Clinical, and Marketing to ensure regulatory pathways align with business goals.
- Monitor and interpret U.S. regulatory changes specific to in vitro diagnostics (IVDs) and Point of Care Testing, proactively informing project direction and providing ongoing education to teams on evolving regulatory landscapes.
- Provide on-market support for tasks such as:
- Product labeling and promotional materials (as assigned)
- Corrective and Preventative Action (CAPA) Regulatory Assessments
- Risk management files
- Post-market surveillance
- Verifications and validations
- Assessing the impact of changes on product performance and safety
- Assess product and manufacturing changes to ensure compliance with applicable regulations.
Ready to make an impact? Apply today and let’s shape the future of healthcare.
Note: this is a Fully Remote position; travel may be up to 20%.
SEKISUI offers a competitive compensation and benefits package
The anticipated base salary for this position is $135,000 – $155,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base salary offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position.
ABOUT US:
At SEKISUI Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.