Principal Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Mar, 26

Salary

188300.0

Posted On

05 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, Clinical Investigations, Quality Systems, Regulatory Submissions, Product Development, Clinical Development, Manufacturing, Change Control, Problem-Solving, Research Skills, Project Management, Interpersonal Skills, Technical Guidance, Mentorship

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Bachelor's degree in a scientific or technical discipline. ● Minimum of 7 years' experience in regulatory affairs or related field, or 5 years' experience with an advanced degree (Master's or PhD). ● Proven knowledge of U.S. and EU regulatory requirements for medical devices, including clinical investigations and Quality Systems standards. ● Experience authoring a variety of regulatory submissions (510(k), PMA, CE Mark under MDR, etc.). ● Solid understanding of product development, clinical development, manufacturing, and change control. ● Strong problem-solving and research skills, along with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. ● Previous experience in the medical device industry, specifically with Class II or III devices. ● Prior direct experience interacting with the FDA, Notified Bodies, or international regulatory authorities. ● Ability to work independently and manage multiple complex projects simultaneously. ● Demonstrated leadership, strategic thinking, and project management capabilities. ● Experience with capital equipment or software-based medical devices. ● Strong interpersonal skills and ability to clearly communicate complex regulatory concepts. ● History of providing technical guidance, training, or mentorship within Regulatory Affairs or cross-functional teams. LI-Hybrid Requisition ID: 620052 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 be responsible for ensuring compliance with U.S. and EU regulatory requirements for medical devices. This includes authoring regulatory submissions and managing multiple complex projects simultaneously.