Senior Regulatory Affairs Specilist

Branford, CT 06405

Posted: 02/23/2024 Industry: Professional Job Number: SC474524111

Job Description

Senior Regulatory Affairs Specialist

Join our client's organization in Branford, Connecticut, dedicated to safety, quality, and customer satisfaction. Lead their operations with a winning attitude and drive for excellence.

WHAT IS GREAT ABOUT THIS OPPORTUNITY?
  • Competitive salary of $100,000/year - $120,000/year annually, reflecting your expertise and technical skills
  • Direct Hire opportunity: Enjoy stability, growth opportunities, and direct access to client’s benefits
  • Remote position: Be at the forefront of change and collaborate with a dedicated team remotely
  • Join their team to embark on a career journey with ample room for growth and professional growth
DO YOU ALIGN WITH THESE KEY QUALIFICATIONS?
  • Bachelor’s Degree with a minimum of five years of related work experience or the equivalent combination of education, experience, and training. 
  • A minimum of 5 years in an FDA regulatory industry is required.  Strong experience in the medical device industry is highly preferred
  • Experience working with health ministries and agencies around the world, including FDA and the European Union, required
  • Specific experience with regulatory submissions and maintenance of international registrations outside of US (e.g., Asia-Pacific, Latin America, etc.) is preferred
  • Experience implementing regulations into Quality Systems
  • Regulatory Affairs Professional Society (RAPS) certification preferred
  • In-depth knowledge of medical device regulations
  • Proficient in Microsoft Office Suite or related software
WHAT WILL YOUR SUCCESS LOOK LIKE? 
As the Senior Regulatory Affairs Specialist, you will facilitate and support regulatory affairs, activities, projects, and initiatives.
WHAT WILL YOU DO?  
  • Preview and review change notices to assess regulatory status impact
  • Assist with regulatory approval application preparation and submission process
  • Review labeling and promotional materials to ensure compliance with FDA, European Union, and other international requirements
  • Assist with FDA customs import/export requests, customer service needs, and other requests from internal or external customers
  • Initiate and update technical files and registrations, as necessary
WHAT WILL YOU RECEIVE?
Gain access to The Reserves Network Team: 
  • Partnership with experienced recruiters who will advise you on all aspects of your job search and career aspirations
  • Our network has direct access to hiring managers, and we will get your resume to the top of the pile of submissions for this opportunity and many more like this
  • Long-term career partner who will provide you with market intelligence and guidance 
Client Benefits: 
  • Industry competitive salary based on your experience/qualifications
  • Health, Vision, and Dental Insurance
  • 401(k) plan
  • PTO
And much more!
 DO YOU WANT TO KNOW MORE?
If you have a background that aligns well with the description of the Senior Regulatory Affairs Specialist and would like to learn more about this opportunity, please apply below NOW!  
Studies have shown that people are likely to only apply for jobs if they meet every qualification. At The Reserves Network, we strive to provide the best experience and opportunities for everyone, so if you are excited about this role but your experience doesn’t align perfectly with every qualification listed, we still encourage you to apply. You may be the right candidate for this or other available roles.
As an equal opportunity employer, we value our employees and foster an environment of respect, integrity, and trust in every aspect of employment. However you identify, and whatever your background, we encourage you to apply today. 

 
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