Senior Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

156900.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, Quality Systems, Clinical Investigations, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe Acrobat, Class II Medical Devices, Class III Medical Devices, FDA Interaction, International Regulatory Authorities, Software as a Medical Device, Communication Skills, Problem-Solving, Project Management, Interpersonal Skills

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Minimum of a Bachelor's degree or equivalent work experience. ● Minimum of 4 years' experience in regulatory affairs or related disciplines within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Post-Market Surveillance). ● Demonstrated proficiency with U.S. and international regulatory requirements for medical devices, including Quality Systems standards and clinical investigations. ● Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. ● Bachelor's degree in life sciences, engineering, computer science, or a related field. ● Previous experience with Class II or III medical devices. ● Prior experience interacting directly with the FDA, notified bodies, or international regulatory authorities. ● Regulatory experience with software as a medical device (SaMD). ● Strong written and verbal communication skills with the ability to convey complex ideas clearly. ● Solid technical, research, and problem-solving abilities. ● Proven ability to manage multiple projects and priorities effectively. ● Strong interpersonal skills and a collaborative mindset. Requisition ID: 619644 Minimum Salary: $82600 Maximum Salary: $156900 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 Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with U.S. and international regulatory requirements for medical devices. This includes managing multiple projects and priorities effectively while interacting with regulatory authorities.