Director, Regulatory Affairs
Company: SEKISUI Diagnostics
Position: Director, Regulatory Affairs
Location: San Diego, CA or Burlington, MA
Posted: October 19, 2021
Have a passion for Regulatory Affairs?
As the Director, Regulatory Affairs you will develop and lead regulatory strategies and implementation plans, in collaboration with project teams, and oversee all plans to a successful outcome. You will liaise with the regulatory bodies or third-party service providers to understand requirements for successful submissions, clearances, and approvals for SEKISUI Diagnostics products. You will manage, coach, and develop the regulatory team to ensure skills are aligned with a high performing organization. Along with your team, you will support currently marketed products by reviewing engineering, product, and labeling changes and ensuring all compliance documentation is complete, accurate, and meets standards and regulations where the products are on-market.
You possess a depth and knowledge of IVD experience AND working with Clinical Affairs: protocol development, study modification, and final report approval. You have been instrumental in supporting the initiation of clinicals, sample preparation, targeted clinical outcomes (as related to a successful submission). You understand verification of submission intended use via clinical trials and/or clinical evaluations – ensuring the clinical outcomes will support the intended use, supporting but not managing the clinical trial or evaluation.
Additionally, in the event the Person Responsible for Regulatory Compliance (PRRC) is not available, you will act on their behalf.
To be successful in this role, you will use your extensive knowledge in IVD, global regulations, specifically USFDA, Canada, and EMEA, to develop strong regulatory strategies, create contingency plans, ensure timely decision-making, and drive accountability through project teams. You will leverage your experience managing complex submissions and technical documentation (instrumentation, hardware, software and reagents) for US FDA 510(k), EU CE mark products, and Rest of World (ROW) submissions in accordance with global regulatory requirements. You will utilize your understanding and application of both the design control process and the process to obtain Clinical Laboratory Improvement Amendments (CLIA) waivers.
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.
If this is your passion and mission, we want to talk with you. please apply for immediate consideration.
Sekisui Diagnostics offers a competitive compensation and benefits package
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.