Regulatory Affairs Specialist Ii

Job PurposeYou 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 ResponsibilitiesWorking as part of a team responsible for Regulatory Activities, with specific responsibility for Renal Denervation devicesRepresent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycleAct 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 processPrepare and submit regulatory documentation and applications focused on compliance requirementsReview and approve product and manufacturing changes, device labeling, and advertising materials for compliance with regulatory requirementsContinuously assess ways to improve Quality and supports and maintains Quality initiatives in accordance with BSC Quality PolicySupports efforts to continuously improve department and divisional processes/practices, including collaboration, best practices, and knowledge sharingParticipates in Regulatory Body audits such as FDA, DEKRA, BSI, HPRARequired qualifications/experienceA minimum of a Level 8 HETAC qualification in Science/Engineering or related disciplineMinimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industryExcellent 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, PowerPoint and Adobe AcrobatPreferred qualifications/experienceExperience working in a dedicated Regulatory Affairs role in Medical Devices or related Industry is strongly preferredWorking knowledge of FDA, EU, and international regulations for medical devicesQuick learner, self-motivated, and independent worker with minimal supervisionWorks well in fast-paced cross-functional team environmentsAbout Boston ScientificAs 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.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 youLegal and Equity StatementAt 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 ******.#J-*****-Ljbffr