What are the responsibilities and job description for the Senior Manager Regulatory Affairs position at SEKISUI Diagnostics?
About you:
You are a seasoned professional with over 10 years in the Regulatory Affairs space with specific experience with IVD and POC products. You are known as the Regulatory point of contact as you support regulatory needs in all aspects of the business, from product development, to manufacturing and post market needs. You have experience in the past 5 years with US regulatory affairs submissions such as 510(k) and PMA. You are an approachable leader who can coach and develop the team you manage while also providing sound guidance and knowledge to the cross functional teams you support.
To be successful in this role you will use your previous experience with various regulatory affairs submissions to lead our submissions using your expertise to anticipate and proactively address challenges when preparing 510(k) and other regulatory registrations. You will act as the regulatory liaison between teams, leadership and regulatory agencies to ensure effective communication between all parties.
Additional Information: This is a US based remote-eligible position; anticipated travel up to 30%
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.
SEKISUI offers a competitive compensation and benefits package
Equal Opportunities:
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.
The anticipated base compensation for this position is $150,000-$170,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base compensation 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.
Salary : $150,000 - $170,000
