Principal Regulatory Affairs Associate
Principal Regulatory Affairs Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Additional Locations:Canada-ON-Mississauga; Canada-ON-Toronto
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.
About this role:
The Principal Regulatory Specialist will support regulatory activities for the Access Solutions Franchise within the Electrophysiology this role you will develop and implement regulatory strategies to support product development approvals and ongoing regulatory compliance. You will collaborate closely with cross functional teams to influence and drive decisions that align with business objectives and regulatory requirements. The position requires strong leadership communication and strategic thinking to ensure regulatory success in a dynamic and fast paced environment.
At Boston Scientific we value collaboration and synergy. This position follows ahybrid work model requiring employees to be onsite at a local Boston Scientific office at leastthree days per week.
Please note thatrelocation assistance is not availablefor this role at this time.
AdditionallyBoston Scientific does not offer sponsorship or assume sponsorship of employment visasfor this position
Your responsibilities will include:
- Develops and implements regulatory strategies for new and modified products
- Acts as a core member on new product development and sustaining teams providing regulatory feedback and guidance throughout the product and manufacturing process development cycle and coordinating team inputs for submissions
- Prepares and submits regulatory applications as well as internal regulatory file documentation
- Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Provides guidance to other team members during strategy formulation submission preparation and interaction with regulatory bodies
- Supports international regulatory partners with commercial marketing applications
- Supports efforts to continuously improve department and divisional quality including collaboration best practices and knowledge sharing
- Supports external audits and maintain audit readiness
Required Qualifications:
- Minimum of a Bachelors Degree in a scientific or technical discipline
- Minimum of 7 years of experience in the medical device industry or 5 years experience with an advanced degree (Masters or PhD)
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
- Demonstrated experience authoring/supporting a variety of regulatory submissions
- Demonstrated ability to effectively lead multiple regulatory projects and priorities
- Excellent written and oral communication technical writing and editing skills
- Ability to articulate complex ideas clearly both verbally and in writing
- Ability to work independently with minimal supervision as well as mentor/guide others
Preferred Qualifications:
- Demonstrated leadership strategic thinking project planning and project management skills
- Understanding of product development process and design controls
- Familiarity with international regulatory requirements
- Excellent organizational communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Requisition ID:609728
Minimum Salary: $95600
Maximum Salary: $189800
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. 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 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 salaried non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
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.
So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre 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!
Required Experience:
Staff IC
Employment Type
Full Time
