Title: Senior Regulatory Affairs Specialist
Location: 1000 Lake Hazeltine Drive Chaska MN 55318 United States
Duration: 12+ months (with possibility of extension)
Shift: 8:00am - 5:00am
The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbents primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities. Responsibilities may include: - Administration of the companies 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.
- Bachelor’s degree in field with 5+ years exp. OR Master’s degree in field with3+ years exp.
- Medical Technologist background and IVD experience strongly desired.
- Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
- Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics.
- Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and IVD in vitro diagnostics. Experience in registration and commercialization of medical device and diagnostic products.
- Ability to develop effective regulatory strategies and apply regulations to premarket strategies.
- Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.
- Proven leadership and managerial skills in order to build and sustain a vision for the work group.
- Demonstrated track record of developing organizational capability.
- Global experience leading and/or participating on cross functional teams.
- Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean
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!