Brasseler USA Inc.
US Regulatory Affairs Specialist
Brasseler USA Inc., California, Missouri, United States, 65018
US Regulatory Affairs Specialist page is loaded## US Regulatory Affairs Specialistremote type:
Work from Homelocations:
United States - Remotetime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R131914This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company’s ongoing compliance.**KEY RESPONSIBILITIES:*** Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.* Initiate and maintain medical device product registrations globally, focusing on international markets.* Support the development of Regulatory strategies and processes.* Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.* Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.* Assist in SOP development and review.* Provide regulatory input to product lifecycle planning.* Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions* Determine and communicate submission and approval requirements* Participate in risk benefit analysis for regulatory compliance* Assess the acceptability of quality, preclinical and clinical documentation for submission filing* Compile, prepare, review and submit regulatory submission to authorities* Monitor impact of changing regulations on submission strategies* Monitor applications under regulatory review* Provide support during inspections and formulating the appropriate response and corrective actions* Assist compliance with product post marketing approval requirements* Review regulatory aspects of contracts* Assist with label and Instructions for Use (IFU) development and review for compliance before release* Ability to manage multiple establishment and product registration activities* Submit and review change controls to determine the level of change and consequent submission requirements* Provide regulatory input for product recalls and recall communications* Other duties as assigned.**SPECIFIC KNOWLEDGE & SKILLS:*** 2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.* Experience with FDA pre-market submissions preferred.* Experience with ISO 13485 and EU MDR preferred**GENERAL SKILLS & COMPETENCIES:*** Good understanding of industry practices* Proficient with tools, systems, and procedures* Basic planning/organizational skills and techniques* Good decision making, analysis and problem solving skills with ability to multi-task* Good verbal and written communication skills* Good presentation and public speaking skills* Good interpersonal skills* Basic conflict resolution skills* Developing professional credibility**MINIMUM WORK EXPERIENCE:**Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.**PREFERRED EDUCATION:**Typically a Bachelor's Degree or global equivalent in related discipline.**TRAVEL / PHYSICAL DEMANDS:**Travel typically less than 10%. Office environment. No special physical demands required.The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.This position is eligible for a [bonus/incentive] not reflected in the posted range.Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers**Fraud Alert***Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment.**Please be advised that Henry Schein's official U.S. website is* *. Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal.**No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.*Over
Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the GreatDepression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.
Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries andterritories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.
We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our
as our founders would have wanted. We live those values by ensuring that our culture focuses on the
of our team, which we accomplish by providing a
for individuals to develop and contribute authentically, with opportunities to and the communities where we live and work.
No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.US Candidates: jobsupport@henryschein.com UK and Ireland Candidates: #J-18808-Ljbffr
Work from Homelocations:
United States - Remotetime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R131914This position is responsible for acquiring and maintaining product registrations for domestic and international markets. Provide direction to the business as necessary regarding applicable U.S. and international regulations. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the company’s ongoing compliance.**KEY RESPONSIBILITIES:*** Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.* Initiate and maintain medical device product registrations globally, focusing on international markets.* Support the development of Regulatory strategies and processes.* Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets.* Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations.* Assist in SOP development and review.* Provide regulatory input to product lifecycle planning.* Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions* Determine and communicate submission and approval requirements* Participate in risk benefit analysis for regulatory compliance* Assess the acceptability of quality, preclinical and clinical documentation for submission filing* Compile, prepare, review and submit regulatory submission to authorities* Monitor impact of changing regulations on submission strategies* Monitor applications under regulatory review* Provide support during inspections and formulating the appropriate response and corrective actions* Assist compliance with product post marketing approval requirements* Review regulatory aspects of contracts* Assist with label and Instructions for Use (IFU) development and review for compliance before release* Ability to manage multiple establishment and product registration activities* Submit and review change controls to determine the level of change and consequent submission requirements* Provide regulatory input for product recalls and recall communications* Other duties as assigned.**SPECIFIC KNOWLEDGE & SKILLS:*** 2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions.* Experience with FDA pre-market submissions preferred.* Experience with ISO 13485 and EU MDR preferred**GENERAL SKILLS & COMPETENCIES:*** Good understanding of industry practices* Proficient with tools, systems, and procedures* Basic planning/organizational skills and techniques* Good decision making, analysis and problem solving skills with ability to multi-task* Good verbal and written communication skills* Good presentation and public speaking skills* Good interpersonal skills* Basic conflict resolution skills* Developing professional credibility**MINIMUM WORK EXPERIENCE:**Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience.**PREFERRED EDUCATION:**Typically a Bachelor's Degree or global equivalent in related discipline.**TRAVEL / PHYSICAL DEMANDS:**Travel typically less than 10%. Office environment. No special physical demands required.The posted range for this position is $61,812-$84,992, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.This position is eligible for a [bonus/incentive] not reflected in the posted range.Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers**Fraud Alert***Henry Schein has recently been made aware of multiple scams where unauthorized individuals are using Henry Schein's name and logo to solicit potential job seekers for employment.**Please be advised that Henry Schein's official U.S. website is* *. Any other format is not genuine. Any jobs posted by Henry Schein or its recruiters on the internet may be accessed through Henry Schein's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with Henry Schein are advised to verify the job posting through this portal.**No money transfers, payments of any kind, or credit card numbers, will EVER be requested from applicants by Henry Schein or any recruiters on its behalf, at any point in the recruitment process.*Over
Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the GreatDepression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.
Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries andterritories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.
We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our
as our founders would have wanted. We live those values by ensuring that our culture focuses on the
of our team, which we accomplish by providing a
for individuals to develop and contribute authentically, with opportunities to and the communities where we live and work.
No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.US Candidates: jobsupport@henryschein.com UK and Ireland Candidates: #J-18808-Ljbffr