Senior Regulatory Affairs Specialist - Endoscopy at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

164500.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, FDA Regulations, EU MDR, International Regulations, Product Development, Design Control, Clinical Trials, Project Management, 510(k), PMA, IDE, Technical Writing, Microsoft Office, Communication Skills, Editing Skills

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Develop and implement regulatory strategies for new and modified medical devices Support associated global submissions in accordance with applicable regulations Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline Minimum of 4 years' experience in Regulatory Affairs within the medical device industry Strong working knowledge of FDA, EU MDR, and international medical device regulations General understanding of product development and design control processes Familiarity with regulations related to the conduct of clinical trials Ability to manage multiple regulatory projects simultaneously Experience preparing and submitting 510(k), PMA, IDE, EU MDR, or international registrations Proficiency with Microsoft Office tools Excellent written and oral communication, technical writing, and editing abilities Demonstrated ability to work independently with minimal supervision * Requisition ID: 615597 Minimum Salary: $86600 Maximum Salary: $164500 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 leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 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.

Responsibilities

Develop and implement regulatory strategies for new and modified medical devices. Support associated global submissions in accordance with applicable regulations.