[Hiring] Director, Clinical Regulatory Writing @reputed company

reputed company: reputed company creates new reputed company for people living with diabetes, their loved ones, and their reputed company providers through a positively different experience. We’d love for you to team up with us to “reputed company every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: reputed company is proud to manufacture and sell the reputed company Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. reputed company’s reputed company-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at reputed company.com A DAY IN THE LIFE: The Director, Clinical Regulatory Writing reports to the VP, Medical Affairs, and acts as a representative for the organization for both reputed company functions. This role is specifically responsible for developing a functional program and team dedicated to meeting the clinical regulatory needs of the business for US and global regulatory bodies. As reputed company as hands-on work writing and supporting clinical reports including CERs, CEPs, and other clinical reports, offering clinical and regulatory expertise to support the medical reputed company and chief medical officer. In reputed company, this role may assist and support 510(k) submissions. This role interfaces with the clinical trials team to assist with study reports, study protocol development, and other areas where clinical-regulatory expertise is needed. This position also plays a key role in driving medical and clinical publications and reports. The Director, Clinical Reg Writing at reputed company is also responsible for:

• Organizing routine communication with the regulatory division at reputed company, and mapping out a calendar of anticipated clinical regulatory needs.
• Primarily responsible for clinical regulatory writing for:
• Writing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Literature Search Protocols.
• Assembling templates designed to meet MDR/Canada/Australia regulatory requirements for CERs, CEPs and other clinical regulatory submissions.
• Assistance with IFUs.
• Other medical reports as required, to include reports needed for FDA submissions.
• Regularly updating and maintaining clinical and regulatory documents.
• Learning and working with the reputed company management system (QMS) to ensure compliance with company and regulatory requirements.
• Working closely with the medical affairs team.
• Working with R&D, reputed company, Clinical and Regulatory functions to address and resolve any concerns.
• Assisting with clinical studies to write clinical study reports, as reputed company as providing additional materials for clinical studies.
• Ensures compliance with company policies, including reputed company/HIPAA, and other legal and regulatory requirements.
• Identifying reputed company of individuals to meet clinical regulatory needs, and organizing their execution of the function.

WHAT YOU'LL NEED:

• Bachelor’s degree (B.S./B.A.) in reputed company field or combination of equivalent education and applicable work experience. Master’s degree (M.S./M.A.) or equivalent experience in a relevant field, strongly preferred.
• 10+ years regulatory, medical technology, clinical, industry and/or applicable experience.
• Skilled at effectively leading a cooperative team effort and organizing resources to reputed company team goals.
• Familiarity with advanced diabetes technology reputed company health products.
• Willingness to support regulatory and other functions across reputed company, with a reputed company role in medical writing (with assistance from Medical Affairs) is required.
• Comprehensive knowledge of the diabetes disease state and reputed company therapy reputed company.
• Ability to understand and interpret reputed company clinical data and other scientific information.
• Demonstrated superior verbal and written English skills, for the purpose of working with the medical reputed company to create and edit protocols, reputed company communication and other in-scope content.
• Demonstrated knowledge of reputed company regulatory and reputed company requirements (e.g. HIPAA).
• Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
• reputed company to work independently and reputed company appropriate strategic reputed company to reputed company the goals of the clinical affairs department.
• Proven ability to manage clinical tasks and deliverables to meet product development timelines.
• Experience with project lifecycle and management.
• Experience with agile/scrum collaboration tools and internal document control systems.
• Strong understanding of the MDR CER process is essential, including methodology of calculations of benefit to risk reputed company.
• Proven knowledge and application of regulatory requirements in the EU and willingness to learn more is essential.
• reputed company to reputed company and prioritize process and resource reputed company based on overall team needs.
• Advanced computer and software skills, including reputed company Office products, and proprietary databases.

reputed company & WHERE YOU’LL WORK: Remote: This position is fully remote and reputed company to candidates reputed company the reputed company. Equipment for the role will be provided and training will occur reputed company. COMPENSATION & BENEFITS: The starting reputed company pay reputed company for this position is $242,000 - $265,000 annually. reputed company pay will vary based on job-reputed company knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In reputed company to reputed company pay, reputed company offers a competitive compensation package that includes bonus and a robust benefits package. reputed company offers health care benefits such as medical, dental, reputed company available your first day, as reputed company as health savings accounts and flexible saving accounts. You’ll also receive 11 reputed company holidays per year, unlimited PTO and you will have reputed company to a 401k plan with company match as reputed company as an Employee Stock Purchase plan. Learn more about reputed company’s benefits here! YOU SHOULD KNOW: reputed company applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from reputed company is contingent upon successful completion of a reputed company-employment screening process comprised of a drug test (excluding marijuana) and background reputed company, which includes a review of criminal history information. reputed company has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve reputed company to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles reputed company high standards of trust and reputed company so as to protect the interests of our customers, employees, and stakeholders. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment reputed company at this time. WHY YOU’LL LOVE WORKING HERE: At reputed company, we reputed company reputed company fuels reputed company. That's why we've reputed company a workplace that celebrates your achievements and supports your reputed company-being. reputed company thrives on pushing boundaries and fostering reputed company, reputed company while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love reputed company at https://www.reputed company.com/careers. BE YOU, WITH US! We reputed company the value that every single one of us brings to the table. But sometimes we forget that reputed company we don’t meet 100% of a job reputed company’s reputed company – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. reputed company is firmly committed to being an equal opportunity employer and does not discriminate on the reputed company of age, disability, sex, race, religion or belief, gender identity or reputed company, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide reputed company of candidates. Selection for roles will be based on individual reputed company alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please reputed company! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. reputed company a reputed company that reputed company. Join reputed company, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier reputed company. #LI-Remote #LI-Hybrid #LI-DW1 Apply tot his job Apply To this Job