Regulatory affairs associate job description

As our Regulatory Associate, you're responsible for providing regulatory support to certain areas of the business, and supporting the activities of more senior Regulatory staff. The Regulatory Associate also has primary responsibility for answering routine questions from the business or from customers, such as SDS requests.
Here's what you can expect every day:


ESSENTIAL JOB FUNCTIONS


Support new product launches by reviewing labels for FHSA compliance and authoring compliant Safety Data Sheets using Product Vision software Register new pesticide products with EPA and states Respond to EPA Data Call-Ins for registered pesticides Renew/maintain existing state and federal pesticide registrations Complete periodic reporting for pesticide sales and production (California mill tax, EPA pesticide establishment report, etc.) Track state and federal regulations that will impact Cleaners products Classify products for transportation according to DOT, IMDG, and IATA regulation Respond to routine requests from outside customers
Required Skills

B.S. in science or engineering Computer and database skills including Excel, Word, Product Vision and SAP. At least 3 years related experience
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ABOUT US


Solving challenges is the very foundation of who we are. After all, in the beginning, our founder, sea captain Robert Fergusson, didn't particularly care about paint. When he founded our company in 1921, he just wanted to keep his ship intact and stumbled upon a valuable solution. Today, that discovery is Rust-Oleum Corporation.

The same passion that drove the Captain to spend his next few years creating the world's first rust-preventative paint still drives us today. When we see a problem, we work diligently until we've perfected a solution, which has led to some of the most cutting edge, durable and innovative products in the industry. Our creative and talented team of over 3000 people across every corner of the world, help us remain the global leader in protective paints and coatings for both home and industry.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity

As we continue to grow, we are seeking a Senior Regulatory Affairs (RA) Associate whose primary responsibility will be to support the regulatory affairs registration team and base business operations for product clearance data in both Clinical Laboratories and Transfusion Medicine business fields. As a Senior RA Associate, you will provide support to the global regulatory team and support product clearances to all markets. This position is based in Rochester, NY. Hybrid work schedules will be considered.

The Responsibilities:
Provide support to the regulatory team including ordering Certificates of Free Sale, requesting legalization of registration documents, and maintaining registration databases.Provide international regulatory support to Clinical Laboratories and Transfusion Medicine product lines as required.Support base business activities, such as reviewing device changes and registration requests in allocated markets.Support and maintain the global product clearance database to provide objective evidence of registration.Identify and/ or support process improvement projects to streamline current activities and increase department efficiencies.Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skillset in Regulatory affairs.

The Individual
Bachelor's degree in a Scientific or related field is required.Minimum 3 years of regulatory affairs or business-related experience required.Prior experience within IVD / Medical Device industry is preferred, but not essential.Excellent interpersonal, teamwork and verbal/written communication skills are required.Good organizational skills and an ability to manage multiple tasks/projects/priorities The ability to demonstrate model behavior understanding priorities and encouraging others to drive for results will be needed.The ability to work with business partners across geographies and time zones is critical.

EOE/AA Disability/Veteran

#LI-SC1

Our R&D Team is looking for a Regulatory Affairs Co-Op for the Summer of 2023! All Co-Ops start June 6th, 2023 and are 6 months long.

Position location: We're all about flexibility! This will be a hybrid role based out of our corporate headquarters in Lakeville, MA location with Mondays & Fridays remote.
A Day in The Life of a Regulatory Affairs Intern:
Work side by side with recognized experts in food regulatory/nutrition compliance Provides scientific support and documentation in support of the labeling and messaging for new/updated products Offers technical support to systems/teams that are part of the Regulatory Affairs day to day operations Under the guidance of subject matter experts in global food regulatory & compliance and using your knowledge of USA food law and food science as a basis, you will help update customer-facing product documentation to generate speed-to-market for our USA/ Canada and global business Support our internal nutrition database in Genesis used for creating mandatory label information by identifying gaps, adding new information, correcting errors, and formatting data fields for easy transition to a future Product Lifecycle Management system Strong growth mindset and curiosity - vision for how to achieve growth and success coupled with willingness to explore new things Operates well in a fast-past environment, self-starting, and willingness to clarify ambiguity

What We're Looking For:
Currently pursuing M.S. in Regulatory Affairs of Food or in Food Science or Food ChemistryB.S. in Food Science and working knowledge of US food laws and regulations, international food regulation knowledge a plus Passion for Food industry & Regulatory AffairsTechnical Depth and CuriosityThrives in ambiguity Strategic and influential Strong Business AcumenData management skills Strong Communication Skills

Compensation/Benefits:
Competitive hourly wage Direct exposure to Senior Leadership TeamWhere applicable: one-time relocation stipend to assist with relocation costs for the SummerFun & Informative events which may include plant tours, bog tour and more!Interact and network with interns across a variety of job functions Work cross functionally for a purpose-driven, farmer-owned co-operative

Who We Are:
You might have our iconic cranberry juice in your fridge or have gotten into heated holiday debate about what's better - canned or fresh cranberry sauce. But did you know that the hardworking people growing the superfruit in our products are 700 family farmers that own our cooperative? They entrust us with what is most precious to them to create new and innovative products that will delight consumers and grow this beloved brand today and into the future.Team members, farmers, consumers and communities alike--we value what makes us unique and strive to connect our farms to families for a better life by living our values:
Grower Mindset - We embrace our grower-owners innovative spirit and heritage through confidence, learning and focus on the future.Sustainable Results - Guided by purpose, we are focused on delivering results for our grower-owners.Integrity Above All - We are ethical, doing the right thing for our grower-owners, customers, consumers and each other Inclusive Teamwork - We build diverse and inclusive teams that strengthen our cooperative.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.