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Regulatory Affairs Manager (Hybrid) - Streetsboro, OH

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Date: Aug 4, 2022

Location: Streetsboro, OH, US

Company: Getinge

 

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.

Company Profile:

Talis Clinical, LLC provides health technology supporting clinicians to impact patient safety and improve outcomes. The team at Talis Clinical is committed to developing technologies that provide enhanced safety and mitigation of adverse clinical events, while providing an intuitive, productive user experience.
We are a fast-paced organization with a culture orientated toward higher purpose outcomes and principles. This will be the most meaningful work you can do.

 

Status: Full-Time, On-site

 

Responsibilities

•    As a Regulatory Affairs Manager, you will be responsible for...
•    Providing regulatory expertise to assigned projects from product concept to product end of life.
•    Development of Regulatory Strategies and Plans for products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
•    Prepare and submit US FDA 510(k) premarket notifications and other product submissions according to FDA guidelines.
•    Support the compilation of EU Technical File and Declaration of Conformity documents (MDR, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.
•    Support the international regulatory specialists with inputs, as needed, into the registration packages they prepare.
•    Maintain expertise in domestic and international regulations and standards, with a regional focus on the US (FDA), EU (MDR), and CA (Health Canada).
•    Manage the internal Business System assessment program.

 

Preferred Experience

•    3+ years of experience in the medical device / medical software
•    Successful preparation and submission of 510(k), PMA, or international documents or registration, labelling and marketing of medical device worldwide
•    Compiling EU Technical File and Declaration of Conformity documents (EU MDR, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.
•    Working directly with Notified Bodies for 3rd party product certifications organizations
•    Working knowledge of medical device regulations (21CFR), FDA law, EU MDR, other global laws, regulations and standards
•    Supporting international registrations and clinical investigations

 

Required Skills

•    Ownership - Willingness to take ownership of a problem and drive to implementation of the solution as an individual and as a team player
•    Team Leader - the ability to leverage respect and influence to successfully implement improvements you recommend to the team.
•    Problem Solver – the ability to identify root cause and corrective actions and using your influence implement the required actions successfully.
•    Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization and external contacts.
•    Strategic thinker, with the passion to drive the strategy and the wisdom to make adjustments to achieve the required outcome.
•    Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one. 
•    A common sense, least burdensome philosophy to successfully achieve consistent compliance with all applicable laws, regulations and standards Organized, detail oriented

 

Education

Bachelor’s degree with 3+ years of related experience in regulatory affairs or compliance engineering. Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position.

 

Annual Salary Range / Benefits

•    Please provide salary requirements with resume
•    Major Health-Dental-Vision Insurance, 401K matching, Short Term Disability
•    Great development environment

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Location:  650 Mondial Parkway, Streetsboro, OH 44241
 

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.