Regulatory Affairs Specialist II at Boston Scientific Corporation Malaysia

Galway, Connacht, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Communication, Technical Writing, Interpersonal Skills, Project Management, Quality Assurance, Regulatory Compliance, Team Collaboration, FDA Regulations, EU Regulations, Medical Devices, Self-Motivation, Fast-Paced Environment, Editing Skills, Manufacturing Changes, Device Labeling, Knowledge Sharing

Industry

Medical Equipment Manufacturing

Description

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 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 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

Responsibilities

The Regulatory Affairs Specialist II will represent Regulatory Affairs on core teams and provide regulatory feedback throughout the product development cycle. They will prepare and submit regulatory documentation and maintain relationships with regulators.