Specialist II, Reg Affairs Job

Boston Scientific Osseo, MN
Date: May 16, 2018

Location:Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: (n/a)

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.

Job Purpose:

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process.

Key Responsibilities:

* Under minimal supervision, 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.

* Collaborates with regional business partners in support of international product registrations.

* Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.

* Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.

* Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

* Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline

* 2+ years Regulatory Affairs or other relevant experience (e.g., Quality, DA, Technical writing, Clinical, Pre-clinical), medical industry experience required

* Working knowledge of FDA and international regulations

* General understanding of product development process and design control

* General understanding of regulations applicable to the conduct of clinical trials

* Ability to 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

Quality System Requirements:

* In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

* Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

* Establishes and promotes a work environment that supports the Quality Policy and Quality System.

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 423824

Nearest Major Market: Minneapolis

Job Segment: Medical, Medical Technologist, Law, Compliance, Product Development, Healthcare, Legal, Research