Job Description
Responsibilities: - The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.
- This is a hybrid role (in office 3 days per week) based in Marlborough, MA.
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
- 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.
- Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.
- Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration.
- Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- Reviews device labelling and advertising materials for compliance with global regulations; analyses and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Support and maintain Quality initiatives in accordance with BSC Quality Policy.
- Continuously assess ways to improve Quality.
- Develops and implements departmental and divisional policies and procedures.
- Supports highly technical or major business segment product lines, special projects or strategic initiatives.
Requirements: - A minimum of a bachelor's degree in a scientific, technical, or related discipline.
- A minimum of 8 years Regulatory Affairs experience in the medical industry.
- Prior experience of supporting both the capital equipment as well as single-use disposables.
- Prior experience with 510(k) submissions, EU MDR and international regulatory registrations.
- Working knowledge of FDA, EU and international regulations for medical devices.
- Ability to read and interpret global regulations and standards.
- General understanding of product development process, design control and quality system regulations.
- General understanding of regulations applicable to the conduct of clinical trials.
- Prior experience supporting contract manufactured and/or OEM products.
- Ability to simultaneously manage several projects.
- Proficiency with Microsoft Office.
- Effective research and analytical skills.
- Effective written and oral communication, technical writing and editing skills.
- Ability to work independently with minimal supervision.
Katalyst HealthCares and Life Sciences
Job Tags
Contract work, 3 days per week,