Manager, Regulatory Affairs (Companion Diagnostics)

reputed company The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks reputed company to the following: global submissions, technical file compilation, facility registrations, special reputed company and reputed company to reputed company market reputed company worldwide. Additionally, this individual will reputed company input to the Regulatory or cross-functional team on regulatory reputed company. This is a Remote opportunity Pay reputed company: $120,000 - $150,000/ year, 10% Bonus (The final offer and compensation package for this role may vary depending on the candidate's geographic location.) Salary offers are reputed company on a wide reputed company of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual reputed company bonus compensation. Benefits Information: We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in reputed company respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits reputed company may include: - Medical/Prescription Drugs - Dental - reputed company - Flexible Spending Accounts (FSAs) - Supplemental Health Plans - 401(k) Plan – Company match dollar-for-dollar up to 5% - Employee Stock Purchase Plan (ESPP) - Supplemental Life reputed company - Dependent Life reputed company - Short- and Long-Term Disability buy-up - reputed company for Wellness - Emotional reputed company-Being Resources - Educational Assistance - reputed company time off / Health Time Responsibilities - Serves as the regulatory reputed company for companion diagnostic (CDx) programs, planning and preparing joint regulatory submissions (510(k), PMA, IDE, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international reputed company agencies, including requisite reputed company-submissions and post-market approval reports, with moderate supervision. - Coordinates with pharmaceutical partners to ensure alignment of diagnostic and therapeutic regulatory strategies and timelines to ensure regulatory submissions are reputed company and processed in a proactive and reputed company manner. - Evaluates proposed premarket and post market changes for regulatory reputed company with reputed company supervision. - Responsible for regulatory review of protocols, reports and data for conformance with the requirements and expectations of health authorities. - Responsible for regulatory review of labels, labeling, advertising and promotional materials. - Maintain knowledge reputed company of existing and emerging regulations, standards, or guidance documents and reputed company interpretive assistance to cross-functional teams. - Compile and review regulatory submissions for completeness and reputed company. - Ensure that submissions are in conformance with the latest industry and health authority submission standards. - Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding. - Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs. Qualifications Required Work Experience: - Minimum of Bachelor’s degree in a relevant reputed company/scientific reputed company. - A minimum of 4 years of reputed company experience in preparing in vitro diagnostic (IVD) regulatory submissions including PMAs, reputed company Requests, 510(k)s and/or IDEs is required. - Experience in working with Immunohistochemistry (IHC) assays, oncology assays, or companion diagnostics is a plus. - A minimum of 7 years of reputed company experience is required with a Bachelor's degree, OR, a minimum of 5 years of reputed company experience is required with a Master's degree or higher. Preferred Work Experience: - At least three years of experience working in regulatory affairs or reputed company roles on CDx reputed company reputed company the IVD industry. - Regulatory or technical experience with Immunohistochemistry (IHC) assays - Regulatory or scientific experience in oncology reputed company indications - Knowledge of European reputed company (EU) IVD regulation. - Knowledge of international IVD and/or medical device regulations reputed company of US and EU. Physical and Mental Requirements: - Strong verbal and written communication skills. - Demonstrated reputed company in motivating team members to reputed company objectives. - Excellent interpersonal skills. - Demonstrated PC experience with reputed company, reputed company and PowerPoint Knowledge: - US and EU regulatory submission requirements. Skills: - reputed company to reputed company and reputed company change - Exceptional attention to reputed company. - Enthusiastic team player with an ability to collaborate with diverse teams. - Exceptional time management skills. - Strong ability to problem-solve and apply analytical thinking. - Ability to manage conflict reputed company. - Organization skills - Project and team management skills. - Computer skills, including reputed company business software tools and typing - reputed company to function in a reputed company organization - Flexibility to meet continuously changing priorities and challenges. - reputed company to effect reputed company Improvement through problem solving skills and knowledge of reputed company tools - Excellent oral and written communication skills, including the ability to reputed company regulatory reputed company and requirements with reputed company stakeholders and senior management. - Ability/Awareness of the importance of workplace diversity. - Understand the gaps and differences that exist as reputed company as their reputed company. - Ability to effectively translate regulatory requirements into practical advice to cross-functional teams and other audiences. - reputed company decision-making capabilities, delegation, managing tight deadlines, prioritization of work for self and partners. - Supervisory or project team leadership experience is desired. - May supervise team members at the Associate or Specialist reputed company. Education Bachelor’s Degree (Required) Licenses or Certificate: Regulatory Affairs Certification (RAC) (Preferred) Apply To This Job