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Senior Regulatory Affairs Specialist
1 week ago
Senior Regulatory Affairs Specialist - P4Onsite Location(s): Cork, C, IE
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's 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, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow We are seeking a Senior Regulatory Affairs Specialist on a permanent basis to join our team.
Job Purpose: The Senior Regulatory Affairs (RA) Specialist is responsible for activities which lead to and maintain regulatory approval to market devices.
Additionally, the Senior RA Specialist is responsible for assessment of device changes for regulatory implications.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Cork, Galway or Clonmel.
You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Key Responsibilities: Develop US, EU and international regulatory strategies for approval of medical devicesCoordinate, compile, and submit U.S. and EU regulatory filings for new and modified productsSupport requests from BSC International Regulatory personnel related to submissions, registrations, and change assessmentsDevelop and maintain positive relationships with regulatory body reviewersReview Technical and Labelling documentation for inclusion in regulatory filingsReview product and manufacturing changes for compliance with applicable regulations and impact to regulatory filingsRepresent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement effortsReview clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impactSupport regulatory audits, as requiredIn all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and proceduresEducation & Experience: Required: A minimum of a Level 8 Honours Bachelor's Degree (240 credits) in STEMA minimum of 5 years of regulatory affairs or related experienceDemonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filingsDemonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical DocumentationBasic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe AcrobatPreferred: Strong technical, research and problem-solving skillsAbility to articulate complex ideas clearly both verbally and in writingTeam player with excellent interpersonal skillsDemonstrated ability to effectively manage multiple projects and prioritiesWorks well in fast-paced cross-functional team environmentsPharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantageAs 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 isn't just business, it's personal.
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
At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
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.
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.
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