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Regulatory Affairs Specialist Jobs

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The Manager/Sr. Manager position is office or home based with -30% travel to the Pittsburgh, PA area. This position manages Regulatory Affairs Associates and Specialists. Provides regulatory advice on strategy and manage projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. *LI-LC1 Education...

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Responsibilities: The Senior Regulatory Affairs Specialist will have a strong technical foundation and aptitude coupled with the ability to be a “collaborative facilitator” and leader. Additionally, he/she will have proven creativity and experience in planning, developing and executing strategic RA plans in order to gain and maintain clearances and approvals for products. Responsibilities include...

Regulatory Affairs Specialist I have a permanent job Regulatory Affairs Specialist - 172558 Cleveland OH 44101If interested pl send me your resume asap with Contact number, Immigration status, Expected Salary. Thanks Debdas Patnaik 248 795 0378 ***** Regulatory Affairs Specialist - 172558 The Regulatory Affairs Specialist provides regulatory leadership for Diagnostic Imaging ...

Regulatory Affairs Specialist II - Boston, MA Job Summary Responsible for assisting the team with regulatory filings as necessary to market products. This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an intermediate understanding of products and their use as well as an understanding of the regulatory admissions pr...

Description: PPD is recruiting forRegulatory Affairs Specialists. In this role you will provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will also act as liaison with internal and external clients in the provision and marketing of regulatory affairs services. Responsibilities include but are not limited to: Performing the day to day operatio...

Job Title: Global Director, Regulatory Affairs For a detailed job description including salary information, please reference Job Number 2404, on http://www.coyotesourcing.com/board.html . EDUCATIONAL REQUIREMENTS: BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline EXPERIENCE: Ten or more years of experience in the medical device industry, some preferably in a ...

Labeling Support Specialist (Contract) - Thousand Oaks, CA Experis is hiring for a Labeling Support Specialist to oversee the process for providing quality drug product regional labeling for health authority submissions that reflect regulatory standards and key stakeholder contributions and perspectives. Job Description: The Regional Labeling Support Specialist is knowledgeable in Labeling Regu...

Regulatory Affairs Associate III: Ortho-Clinical Diagnostics, Inc. is seeking a Regulatory Affairs Associate III for our Raritan, New Jersey location to provide domestic and international regulatory support for the Ortho-Clinical Diagnostics franchise, with a focus on the Asia/Pacific region. Position to determine strategies to obtain appropriate approvals and registrations, and prepare complex su...

Regulatory Affairs Specialist Job, Northern, NJ: Our client, a leading manufacturer in the healthcare industry, is currently seeking a Regulatory Affairs Specialist to join their growing team. Successful candidates will have experience developing regulatory strategies for an FDA approved facility. Regulatory Affairs Specialist Job Responsibilities: Coordinate efforts associated with the prepara...

Specific Duties · Maintain all USA (including each state), Canada, and European licenses, registrations, and amendments · Maintains product registration data base for USA and other foreign registrations. · eCTD Submissions: · Assist in building eCTD sequences, formatting, compilation, book marking, hyperlinking, publishing, and QA/QC of electronic regulatory submissions. · Troubleshooting of ...

Become part of a growing team. Collagen Matrix, Inc., located in Oakland, NJ, is expanding our Regulatory team and has an excellent opportunity for a Regulatory Specialistwith experience in writing regulatory submissions. Responsibilities include: · Prepares, or contributes to the preparation of regulatory dossiers and documents for class II and class III medical device submissions. · Particip...

We currently have an excellent opportunity for a Regulatory Affairs Specialist located at our Princeton, NJ location. The Regulatory Affairs Specialist possesses and maintains up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned. Responsibilities: • Maintains current knowledge of products and regulatory requirements affecting products. • ...

Position Summary: The Regulatory Affairs Specialist will be part of the global regulatory team responsible for formula and labeling compliance as well as product registrations worldwide. This person would also be responsible for all regulatory aspects for a specified region of the world. Essential Job Functions: Key Responsibilities: Assist Regulatory Manager in market notifications and regist...

Would you like to join a leading global manufacturer of flavors and fragrances? Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers, and we currently have a contract opening for a Regulatory Affairs Specialist in Schaumburg, IL. The Regulatory Affairs Specialist, Flavors Group will assure compliance of products with appropriate regu...

Position Description: About Volcano We are revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovasc...

Senior Regulatory Affairs Specialist, Orange County, Medical Device, Regulatory Affairs A major Orange County medical device company is urgently seeking a Senior Regulatory Affairs Specialist. This role will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within the domestic and International markets. You will be part of a collaborative and inno...

What matters to you about your work? Do you want to work in an organization with less bureaucracy where you can have a direct, tangible impact? Do you want to know your work matters and improves the lives of thousands of people? How about the opportunity to work for a highly respected company that is in an unmatched growth mode? These are the things that matter to our client, and they are looking...

HELENA LABORATORIES Regulatory Affairs Specialist Helena Laboratories currently has a Regulatory Affairs Specialists position available. Candidate must have broad science background, BS degree in Biology, Medical Technologist or applicable work experience in field. Familiarity with medical device industry (In Vitro Diagnostics) under ISO 13485 FDA Quality System is preferred. Responsibilit...

I. PURPOSE AND SCOPE The Regulatory Affairs Specialist is responsible for maintaining accurate and current data concerning Tender finished goods on governmental and non-governmental databases. The Specialist will facilitate confident reliance on Tender’s institutional knowledge and data. The Specialist will standardize, document, and maintain accessible data. External regulatory agencies, customs...

Regulatory Affairs Specialist Responsibilities: Prepare FDA and international submissions for new products and product changes to ensure timely approval for market release in accordance with applicable regulations, standards, and guidance. Maintain regulatory affairs product files to support compliance with requirements and standards. Maintain the Company’s Medical Device Listing and Device Esta...