Principal Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

, , United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

188300.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Management, Medical Device Industry, U.S. Regulatory Requirements, International Regulations, EU MDR, PIRs Management, CAPAs Management, Recalls Management, Audit Support, Regulatory Submission Software, Cross-Functional Collaboration, Project Management, Detail-Oriented, Organizational Skills, Adaptability

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Bachelor's degree in a scientific or technical discipline; advanced degree preferred. ● Minimum of 5 years' experience in Regulatory Affairs and/or Quality, with at least 2 years' experience specifically in Regulatory Affairs, preferably within the medical device industry. ● In-depth knowledge of U.S. regulatory requirements, with strong preference for experience with international regulations, including EU MDR and other global frameworks. ● Proven experience managing PIRs, CAPAs, recalls, and audit support. ● Proficiency in regulatory submission software and databases. ● Demonstrated ability to work independently as well as collaboratively in cross-functional teams. ● Comfortable adapting to shifting priorities and thriving in a fast-paced, deadline-driven environment. ● Detail-oriented with strong organizational and project management capabilities. LI-Hybrid Requisition ID: 619226 Minimum Salary: $99100 Maximum Salary: $188300 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

The Principal Regulatory Affairs Specialist will manage regulatory submissions and ensure compliance with U.S. and international regulations. Responsibilities include handling PIRs, CAPAs, recalls, and providing audit support.