About the role:
The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.
Your responsibilities will include:
- Develops and implements regulatory strategies for new and modified products.
- Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
- Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
- Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
- Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions)
- Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
- Trains to departmental and divisional policies and procedures
- Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives
- Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
Required qualifications:
- A minimum of a Bachelor’s degree, preferably in a scientific or technical discipline
- A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
- Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices
- Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices
- Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices
Preferred qualifications:
- Demonstrated experience of regulations applicable to the conduct of clinical trials
- Prior experience with regulatory submission writing
- Demonstrated understanding of product development process and design controls
- Demonstrated knowledge of FDA, EU and/or international regulations
- Ability to manage several projects simultaneously
- Effective research and analytical skills
- Excellent written and oral communication, technical writing and editing skills
- Ability to work independently with minimal supervision
- Strong interpersonal and influencing skillsProficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)
Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
