Principal Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

188300.0

Posted On

07 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Leadership, Project Planning, Global Regulatory Requirements, Influence, Negotiation, Medical Device Regulations, Quality System Standards, Clinical Investigation, Product Lifecycle Processes, IDE Preparation, 510(k) Submissions, EU MDR Submissions, Analytical Skills, Technical Writing, Communication Skills

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Bachelor's degree in a relevant scientific or engineering discipline. ● Minimum of 7 years' experience in Regulatory Affairs, or minimum of 5 years' experience with an advanced degree (Master's or PhD). ● Demonstrated leadership in regulatory strategy, project planning, and cross-functional execution. ● Strong experience interpreting global regulatory requirements to align with cost, schedule, and performance goals. ● Proven ability to influence and negotiate with global regulatory authorities. ● Proficiency with U.S. and EU medical device regulations, including Quality System standards and clinical investigation requirements. ● Deep understanding of product lifecycle processes including development, clinical, manufacturing, and change control. ● Hands-on experience preparing IDEs, 510(k)s, and EU MDR submissions. ● Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. ● Excellent analytical, technical writing, and communication skills. ● Direct experience submitting to the FDA, under EU MDR, and to other global regulatory bodies. ● In-depth knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, and MDCG guidance. ● Experience mentoring or guiding junior regulatory staff. ● Prior responsibility as the primary contact with the FDA and/or EU Notified Bodies. ● Ability to manage multiple projects and competing priorities. ● Strong problem-solving skills with a commitment to quality, results, and timely delivery. LI-Hybrid Requisition ID: 620058 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 lead regulatory strategy, project planning, and cross-functional execution. Responsibilities include interpreting global regulatory requirements and preparing submissions to regulatory bodies.