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Actalent
Dallas, TX, United States
Job Title: Regulatory Affairs Associate Job Description The Regulatory Affairs Associate ensures regulatory clearance for all company products across all markets while maintaining compliance with all applicable regulations. This role involves drafting and submitting regulatory registrations in the US and EU, collaborating with R&D to maintain DHF
Job Source: ActalentActalent
Dallas
Description: The overall goal of the Regulatory Affairs Associate is to ensure regulatory clearance for all company products in all markets and compliance with all applicable regulations. The Regulatory Affairs Associate will have a full understanding of the company product portfolio. Principal duties and Responsibilities: • Draft and submit regula
Job Source: ActalentHunt Corporation
Dallas, TX, United States
Job Description Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resources, dispatched by HEN's proprietary TraDER platform. The mission of Hunt is to be a growth-oriented industry leader respected throug
Job Source: Hunt CorporationHunt Corporation
Dallas, TX, United States
Job Description Company Description: Hunt Energy Network (HEN), a subsidiary of Hunt Consolidated, provides world-class solutions for clean energy assets in ERCOT by developing and managing distributed energy resources, dispatched by HEN's proprietary TraDER platform. The mission of Hunt is to be a growth-oriented industry leader respected throug
Job Source: Hunt CorporationActalent
Dallas
Job Title: Regulatory Affairs AssociateJob Description The Regulatory Affairs Associate ensures regulatory clearance for all company products across all markets while maintaining compliance with all applicable regulations. This role involves drafting and submitting regulatory registrations in the US and EU, collaborating with R&D to maintain DHF do
Job Source: ActalentConfidential
Dallas, TX, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Genom
Job Source: ConfidentialHF Sinclair
Dallas, TX, United States
HF Sinclair is seeking a Regulatory and Corporate Affairs Manager to support the Government Affairs and Corporate Management teams to further overall company objectives and identify regulatory and public policy trends. Leads overall strategy related to rulemaking and regulatory changes while working cross functionally to ensure all segments of the
Job Source: HF SinclairConfidential
Dallas, TX, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialDallas, TX, United States
Description:
The overall goal of the Regulatory Affairs Associate is to ensure regulatory clearance for all company products in all markets and compliance with all applicable regulations. The Regulatory Affairs Associate will have a full understanding of the company product portfolio.
Principal duties and Responsibilities:
Draft and submit regulatory registrations in US and EU and ensure project deadlines are met
Work with R&D to create and maintain DHF documents and Technical Documentation
Provide regulatory strategies for product development projects.
Submit notifications of significant changes to competent authorities, notified bodies, and authorized reps
Answer questions from competent authorities, notified bodies, authorized reps, and international distributors and provide documentation as needed
Ensure compliance with regulatory and registration requirements in all jurisdictions
Keep up to date with changes in regulatory legislation and guidance
Conduct annual audits and review contracts of authorized reps and international distributors
Provide regulatory support during third party audits of the company quality system and product documentation
Work with QA to update Post-Market Surveillance plans and reports annually and to submit PSURs and SSCPs as required
Maintain familiarity with company product lines
Advise company regarding policies, practices, and systems to assure compliance with regulations and requirements of competent authorities.
Skills:
regulatory affairs, medical device, regulatory submission, fda, quality assurance
Additional Skills & Qualifications:
Bachelors degree required.
3+ years experience in progressive positions with responsibilities for regulatory affairs in the international medical device market.
Demonstrated success in medical device regulatory submissions in the US and EU under MDR
Highly oriented to customer service and quality improvement.
Ability to work in a fast paced, driven organization.
Strong written and verbal communication skills.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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Email Alert for Regulatory Affairs Associate jobs in Dallas, TX, United States
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