Title: Senior Regulatory Affairs Specialist
Location: Chaska 1000 Lake Hazeltine Drive Chaska MN 55318 United States (Remote Opportunity)
Duration: 12+ Months Contract
Shift: 8am to 5pm
The Senior Regulatory Affairs Representative plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. Your primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities. RESPONSIBILITIES MAY INCLUDE: Administration of the company’s complaint management program for compliance to corporate requirements. Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans. Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting. Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments. Additionally may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications. Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices. EDUCATIONAL AND EXPERIENCE REQUIREMENTS: Bachelor’s degree in field with 5+ years of experience OR Master’s degree in field with 3+ years of experience. Regulatory experience required. Experience in one or more of the following a plus: biochemistry, biomedical, pharmaceuticals, reagents, assays and/or IVD.
Why Work Here?Compunnel Inc. has always been and will always be an Equal Opportunity Employer. Where every individual, solely on their merit, qualification and competency not only has equal economic opportunity but also for recruiting, training and career development. Our 2000+ members reflect a culture of diversity and inclusion and bring their authentic, original and best selves to work. Our inhouse team who looks over no discriminate against any employee and puts affirmative actions has full support of our Chief executive officer Andy Gaur and its top leaders branched out across Compunnel.
Room for growth, excellent work environment!