Skip to main content
X

Get jobs by email for this search

By continuing you agree to Monster's Privacy policy, Terms of use and use of cookies.

Regulatory Affairs Specialist Jobs in Massachusetts

37 jobs

Seeking individual with experience within a medical device, pharmaceutical, or diagnostic testing product manufacturer to join a growing company located in the heart of the Number 1 ranked Biopharma Cluster in the US. Must be able to: *** Assess the existing quality system and implement improvements to reduce or eliminate regulatory compliance risks. *** Conduct internal audits and interface wi...
We are a manufacturer of Class I and Class II medical devices and have an immediate opening for a Medical Device Regulatory Affairs specialist. Responsibilities will includemanagement of all facets of the quality system. Applicant must have a minimum of 5 years’ experience in the maintenance, monitoring and compliance of FDA QSR, GMP’s, ISO13485, CMDR and Medical Device Directive 93/42/EEC regulat...
Job Scope & Purpose: Great opportunity to join our client, a fast growing pharmaceutical company based in Boston committed to deliver innovative therapies that provide hope and healing for patients living with cancer, and is looking to add a Regulatory Affairs Specialist to their team. The successful candidate will be a member of cross-functional teams with the primary focus being on generating r...
Job Description: ------------------ Senior Regulatory Affairs Specialist at fast growing company with $1,000 Hiring Bonus when applying via ReferralMob-------------- Member of the Regulatory team that insures regulatory approvals are effectively obtained and compliance with regulations is maintained. Generate domestic and international product submissions. Lead cross functional teams to insure re...
Kelly Outsourcing and Consulting Group, a division of Kelly Services, Inc., is seeking multiple Regulatory Affairs Specialists with medical device experience for multiple 2+ year project opportunities. These positions come with enhanced benefits (see below). Candidates must able to work onsite at one of the following locations - Raynham, MA; West Chester, PA or Warsaw, IN. The Regulatory Affairs S...
Kelly Services is looking for a Regulatory Affairs Specialist in Mansfield, MA Job Description. This is replacement for Full time Employee Temporary Leave, so they need someone who can step right in with very little training needed. The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for ...
Kelly Services is looking for a Regulatory Affairs Specialist for a large Medical Device client in Mansfield, MA. 6 month contract Looking for an experienced candidate to jump right into an assignment. Summary: The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for medical devices, subm...
Company Description: For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and suppor...
Southborough, MA - The Sr. Regulatory Affairs Specialist will assist the Manager, Regulatory Affairs in obtaining approval to market Gyrus ACMI medical devices in the worldwide markets served by Gyrus ACMI. EOE M/F/D/V Job Duties: * Participate in product teams developing new products to define global regulatory requirements. * Review and approve product labeling. * Work closely with Upstream M...
* An Evergreen Requisition is an advertisement for positions that Olympus hires for throughout the year. It is a way for Olympus to build a database of qualified, interested individuals for a particular job function so that when there is a need to fill that type of role, the hiring process will be faster. By applying to an Evergreen Requisition, you are expressing your interest for a particular jo...
Job Description: The Sr. Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising, mentoring and guiding the local organization on regulatory topics. They are also responsible for providing regulatory support to product development teams...
Job Description: Job Purpose: Member of the Regulatory team that insures regulatory approvals are effectively obtained and compliance with regulations is maintained. Generate domestic and international product submissions. Lead cross functional teams to insure regulatory objectives are completed.Key Results Area: Provide regulatory guidance to product development team to insure the documents the ...
Senior Regulatory Affairs Specialist-161111227 Description Responsibilities: Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction. Develop responses to questions or deficiency letters from regulatory agencies. Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessar...
Job Description DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II – Spine, located in Raynham, MA OR Oberdorf, Switzerland. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, se...
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II – Spine, located in Raynham, MA OR Oberdorf, Switzerland . DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and progr...
Regulatory Affairs Specialist - Medical Device Company Description: SeraCare develops and manufactures controls and reference materials and related products for In vitro diagnostics. We focus on infectious disease, oncology, inherited diseases and maternal fetal medicine. SeraCare is the best in the world at developing and manufacturing disease mimetics which are biosynthetic or engineered versio...
Opportunity: Experience mid-level position which integrates regulatory knowledge throughout the product lifecycle with aspects of effective project management and strategy. The position supports the Regulatory Affairs function by assisting the coordination and preparation of global regulatory premarket submissions. Division Information: The Corporate division is the central operating unit of th...
DePuy Synthes is recruiting for a Senior Regulatory Affairs Specialist , located in Raynham, MA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, spo...
Responsibilities: Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction. Develop responses to questions or deficiency letters from regulatory agencies. Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. De...
FRESENIUS CORE VALUES: Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient e...