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Overview
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.
The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.
We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position Summary :
The Staff Regulatory Specialist performs product registrations and act as the company representative with the applicable regulatory authorities.
The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations.
The Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. Additionally, the position develops Regulatory strategies for new product development and design changes while representing regulatory interest on product development teams.
The Staff Regulatory Specialist advises on the implementation of compliance mechanisms for new and emerging regulations, standards, and regulatory guidances.
This position collaborates with personnel with the business unit and company.
Responsibilities
Key Accountabilities
Design Control : Is Regulatory lead on cross-functional product development teams. Provide team with strategic and tactical guidance regarding global regulatory requirements to support product marketing authorizations.
Review product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
Regulatory Projects : Independently lead multiple long-term projects. Interact with supervisor as required on activities, issues, or turning points.
Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
Marketing Authorizations : Assess and document assessment of regulatory marketing requirements for global markets. Schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals according to governing rules governing rules and regulations of the affected geographies.
Perform or ensure activities to obtain global market authorization in domestic and international geographies including submissions, registrations, apostilles, declarations, license applications, attestations, certifications, design dossiers, and technical documentation, export certificates, and device listings.
Maintain product technical documentation and ongoing activities related to compliance with global regulatory directives and regulations.
Create records in central repository of market authorization deliverables and responses. Represent company in interactions and communications with regulatory authorities to obtain timely market authorizations.
Coordinate with internal personnel to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
Regulatory Intelligence : Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies.
Monitor and analyze the development of new and emerging regulations, guidance, and standards in marketed geographies. Coordinate evaluation of new and emerging standards with Subject Matter Experts.
Assist in the development of plans for meeting and complying with new regulations, guidance, and standards. Develop strategy for complying with new and emerging regulations, guidance, and standards.
Regulatory Strategic and Tactical Management : Assist Regulatory management with development of strategic and tactical options for accomplishing company goals and initiatives.
Implement regulatory strategies and tactics. Manage regulatory consultants when engaged to assist with goals.
Labeling, Advertising, and Promotion Review : Review and approve labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc.
Provide regulatory review and approval for product marketing colletrial.
Quality Management System Support : Assist in the education and broadening the regulatory knowledge within the Werfen teams.
Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities.
Maintain procedures and work instructions related to Regulatory processes. Support Regulatory function and assist other departments in audit and inspection preparation.
Networking / Key Relationships :
Qualifications
Minimum Knowledge & Experience Required for the Position :
Skills & Capabilities :
Knowledge of electronic publishing / file management system.
Travel Requirements :
Limited travel required.
The salary range for this position is currently $140,000-$185,000 annual. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and / or other business and organizational needs.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity / Affirmative Action Employer M / F / D / V.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
Last updated : 2024-06-04
Full Time
$71k-93k (estimate)
05/31/2024
08/24/2024
werfen.com
Bedford, MA
<25
The job skills required for Regulatory specialist include Regulatory Affairs, Product Development, Problem Solving, Written Communication, Leadership, Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory specialist positions, which can be used as a reference in future career path planning. As a Regulatory specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory specialist. You can explore the career advancement for a Regulatory specialist below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
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Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
02/24/2022: Newport News, VA
Earn Regulatory Affairs Professionals Society certifications.
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On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
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At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
Step 3: View the best colleges and universities for Regulatory Specialist.