Job Description - Regulatory Affairs Fellow - Ad Promo
● Bachelor's degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline. ● Minimum of 10 years' experience in Regulatory Affairs or related compliance experience within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices. ● Demonstrated working knowledge of FDA and EU regulatory frameworks impacting medical device promotion and communications. ● Experience evaluating product claims for alignment with cleared or approved indications for use. ● Experience assessing clinical, performance, and bench data to substantiate promotional claims. ● Experience applying regulatory requirements related to fair balance, risk communication, and required disclosures within promotional materials. ● Experience participating in cross-functional promotional review processes or committees. ● Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint. ● Advanced degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline. ● Strong written and verbal communication skills with the ability to translate regulatory requirements into clear, actionable guidance for nonregulatory audiences. ● Demonstrated ability to influence without authority and collaborate effectively within cross-functional teams. ● Strong writing, editing, and critical-thinking skills with attention to detail. ● Organizational skills with an audit-ready mindset and documentation discipline. ● Learning agility and a continuous improvement orientation. ● Pragmatic problem-solving skills and a coaching mindset. LI-Hybrid Requisition ID: 625013 Minimum Salary: $125800 Maximum Salary: $239000 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
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