Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist II on a permanent basis to join our team.
Job Purpose
You will provide regulatory support on a wide variety of Interventional Cardiology devices with a focus on supporting sustaining commercial products and US and EU submission activities. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.
Key Responsibilities
* Working as part of a team responsible for Regulatory Activities, with specific responsibility for Renal Denervation devices
* Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle
* Act as company representative developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, requirements, and full submission review process
* Prepare and submit regulatory documentation and applications focused on compliance requirements
* Review and approve product and manufacturing changes, device labeling, and advertising materials for compliance with regulatory requirements
* Continuously assess ways to improve Quality and supports and maintains Quality initiatives in accordance with BSC Quality Policy
* Supports efforts to continuously improve department and divisional processes/practices, including collaboration, best practices, and knowledge sharing
* Participates in Regulatory Body audits such as FDA, DEKRA, BSI, HPRA
Preferred Education & Experience
* A minimum of a Level 8 HETAC qualification in Science/Engineering 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
* Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators.
* Proven team player with excellent interpersonal skills.
* Demonstrated ability to effectively manage multiple projects and priorities while adhering to time schedules.
* Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat
Preferred Qualifications/experience
* Experience working in a dedicated Regulatory Affairs role in Medical Devices or related Industry is strongly preferred
* Working knowledge of FDA, EU, and international regulations for medical devices
* Quick learner, self-motivated, and independent worker with minimal supervision
* Works well in fast-paced cross-functional team environments
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. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
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