Staff Regulatory Affairs

Company: Net2Source
Location: Chaska
Posted on: March 20, 2023

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.



Job Title: - Staff Regulatory Affairs

Duration: 13 month(s)



Description/Comment:



In this role, you will have the opportunity to: Author global pre-market submissions, including 510(k)s and PMAs to the U.S. FDA in alignment with pre-market and post-market strategies. Create and manage IVDR Technical Files. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes. Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture. Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays. Function as the team expert for promotional material review, experimental design review, data analysis and product labeling as they relate to product registration and commercialization of IVD medical devices. The essential requirements of the job include: Bachelor's Degree with 5+ years of experience in Life Sciences or a Master's Degree with 3+ Years of experience in Life Sciences or Doctorate with 0-2 years of experience in Life Sciences. Subject matter expertise in registration and commercialization of medical devices. It would be a plus if you also possess previous experience in: 510k author. RAC certification



Additional Job Details:

Fully Remote - flexible hours



Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.



Equal Employment Opportunity Statement:

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.



Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)



Priyanshi Srivastava

Lead Pharma Recruiter

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Net2Source Inc.

Global HQ Address: 270 Davidson Ave, Suite 704, -Somerset, NJ 08873, USA

Office: (201) 479 3743 x EXT: 920 - Fax: (201) 221 8131- Email:

Web: - Social: - -

Keywords: Net2Source, Minneapolis , Staff Regulatory Affairs, Other , Chaska, Minnesota