Regulatory Affairs Specialist II at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Feb, 26

Salary

132000.0

Posted On

18 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, FDA Regulations, EU Regulations, Technical Writing, Project Management, Compliance, Post-Market Evaluation, Process Optimization, Microsoft Word, Microsoft Excel, Microsoft Teams, Microsoft PowerPoint, Adobe Acrobat, Communication Skills, Self-Motivated

Industry

Medical Equipment Manufacturing

Description

Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities, audit support, and general compliance initiatives. The role may also include support for new product introductions, evaluation of post-market design changes, and process optimization efforts—aligned with global medical device regulations and broader business objectives. This is a hybrid position based in Maple Grove, MN (in office at least three days per week). * Your responsibilities will include: ● Minimum of a bachelor's degree in a scientific, technical, or related discipline ● Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, including at least 1 year in a Regulatory Affairs role ● Introductory knowledge of FDA and EU regulations for medical devices ● Basic computer skills, including proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat ● Working knowledge of FDA, EU, and international regulations for medical devices ● Ability to manage multiple projects of moderate scope and complexity simultaneously while meeting deadlines ● Excellent written and oral communication, technical writing, and editing skills; ability to translate technical information into clearly written regulatory messaging ● Advanced computer skills to support submission preparation and internal/external communication (e.g., MS Word linkages, section formatting, table of contents creation) ● Self-motivated, quick learner who can work independently with minimal supervision ● Comfortable working in fast-paced, cross-functional team environments LI-Hybrid Requisition ID: 618595 Minimum Salary: $69500 Maximum Salary: $132000 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 role involves managing annual reports, EU MDR PSUR and SSCP annual reviews, and supporting recertification activities. Additional responsibilities include audit support and compliance initiatives aligned with global medical device regulations.