Regulatory Affairs Associate II

2 weeks ago

Minneapolis, Minnesota, United States Boston Scientific Gruppe Full time
About Us:

At Boston Scientific Gruppe, we are dedicated to enhancing lives through innovative medical solutions. Our advanced products and technologies play a crucial role in diagnosing and treating a variety of medical conditions. We are committed to continuous innovation in key sectors and expanding our reach into emerging markets.

In the field of Rhythm Management (RM), we provide comprehensive solutions for managing irregular heart rhythms and heart failure, as well as safeguarding against sudden cardiac arrest.

Our offerings include state-of-the-art 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths.

Boston Scientific is at the forefront of developing, manufacturing, and marketing a wide range of products and services that facilitate less-invasive care for serious cardiac conditions. For nearly two decades, we have been expanding treatment indications and conducting pivotal research, thereby increasing access to life-saving and life-enhancing therapies.


Position Overview:

The Regulatory Affairs Specialist II plays a vital role under supervision, focusing on the planning, management, and execution of regulatory approvals for the FDA, notified bodies, and various international product registrations. This position is essential for maintaining compliance with regulatory agency standards.


Key Responsibilities:
  • Conduct research and provide guidance on international product registration and compliance requirements specific to different countries.
  • Coordinate, compile, and submit regulatory filings for both new and modified products, including IDEs, PMAs, PMA supplements, IDE periodic reports, PMA annual reports, CE Mark dossiers, and other country-specific registrations.
  • Review test protocols and reports to ensure they meet regulatory filing standards.
  • Evaluate labeling, advertising, and promotional materials for compliance and support of claims.
  • Assess product and manufacturing changes for regulatory compliance and their impact on existing filings.
  • Represent Regulatory Affairs in cross-functional teams focused on product development and manufacturing support.
  • Collaborate with clinical affairs on various aspects of clinical trials and reporting.

Qualifications:

Required:
- A bachelor's degree in life sciences, engineering, or a related field.
- A minimum of 3 years of experience in regulatory affairs.

Preferred:
- Familiarity with regulatory requirements for medical devices.
- Strong written and verbal communication skills, along with technical writing proficiency.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
- Experience with submissions for Class II or Class III medical devices.
- Knowledge of US/EU regulatory requirements for medical devices, including Quality Systems standards and clinical investigations.
- Direct experience working with FDA, notified bodies, and/or international health authorities.
- Excellent research, problem-solving, and leadership abilities.
- Capability to articulate complex concepts clearly in both oral and written formats.
- Proven ability to manage multiple projects and priorities effectively.
- A collaborative team player with outstanding interpersonal skills.


Note: This role is classified as safety-sensitive, and candidates will be required to undergo a prohibited substance test as part of the hiring process, in compliance with applicable laws.

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