UNKNOWN

FEED

Accepts responsibility to quickly identify any areas that lack cohesiveness, bringing them to the attention of leadership and working with the team in a supportive manner to resolve issues and actively look for ways, and reinforce actions needed, to achieve synergy possible within the larger organization. quality, security, office environment, company policies, continuous improvement); understands the responsibility to maintain familiarity with the systems and this position's role in support of these systems - including a consideration of the impact of individual actions on the systems and the responsibility to communicate concerns and improvement ideas.

Simmons Prepared Foods

Product & Regulatory Specialist 1

ea_via_bold

At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval.

Houston Methodist Hospital

Regulatory Compliance Specialist - Transplant Center

linkup_via_bold

Work with internal Regulatory Affairs, Quality Assurance, Technical Operations, Supply Chain and labeling teams, as well as CDMOs and other external partners, to obtain required technical documentation, resolve information gaps, align filing and implementation plans, and support continuity of supply. Prepare, review and coordinate CMC submissions and maintenance activities arising from changes, including Canadian Level III notifications and relevant DEL or labeling updates, and U.S. Annual Reports and CBE-0/CBE-30 submissions, as applicable.

YEAR

Medexus Pharmaceuticals Inc

Senior Specialist, Regulatory CMC

ADAPTED_NOW

Additional qualifications that could help you succeed even further in this role include: Master’s degree in occupational health and safety, industrial hygiene, public policy, regulatory affairs, or a related scientific or technical discipline. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

At 3M, inspiration happens daily.
Here, science is how the magic happens.
Except it’s not magic, it’s the right science applied the right way by the people of 3M.
Here, your ideas help shape everyday lives around the globe.
Here, you matter. You inspire. Challenge. Thrive.
At 3M, you’ll receive competitive wages, paid time off, medical, dental, vision, and more!
To apply, visit 3M.com/apply.

Respiratory Protection Regulatory Engagement Specialist

Required Knowledge, Skills and Abilities: 1-3 years in regulatory operations, regulatory affairs, document control, quality, or a related medical device function - or a strong adjacent data/administrative role with regulatory exposure. Maintain the master registration matrix and renewal tracker (license/registration data, classifications, license holder, expiry dates, certificate links), updating weekly from RA Specialists, contractors, and ARs.

Caldera Medical Inc

Regulatory Operations Specialist

FULL_TIME

Works with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements, and to ensure sustainable compliance to customer, state, federal and International regulatory requirements within highly regulated markets such as medical device and FDA. With 22,000 clients, including 93% of the Fortune 100, and 32,000 employees across 28 countries, RRD brings the expertise, execution, and scale designed to transform customer touchpoints into meaningful moments of impact.

Our people make a difference every day - working with customers, in production or behind the scenes in a support role. They know how to manage the job and exceed expectations! Through our dedicated and talented employees we are creating, managing and executing marketing and business communications that are connecting people around the world with the power of words and images.
 
With a long and rich history, RR Donnelley (NYSE: RRD) is a Fortune 500 company employing more than 44,000 people worldwide. We assist customers in developing and executing multichannel communication strategies that engage audiences, reduce costs, drive revenues and increase compliance. 
 
We’re not only committed to innovative technologies. We’re committed to high standards of corporate social responsibility across our global footprint. For details please click here to view the report “making a difference starts with ourselves.” You’ll find out how RR Donnelley defines its values, how we work to ensure our employees feel valued, and how our company efforts add value for our stakeholders.
 
RR Donnelley is an Equal Opportunity/Affirmative Action employer. The company’s policy is to select, place and deal with all its employees without discrimination based on race, religion, color, national origin, sex, gender identity or expression, age, disability, perceived disability, sexual orientation, protected Veteran status, genetic information or on the basis of any other status protected by applicable federal, state or local law.

RR Donnelley

Manager, Quality Assurance & Regulatory Affairs

SmartRecruiters_Organic_Non_Easy_Apply

The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States.

CorDx

Regulatory Affairs Manager - IVD

Manager, Regulatory Affairs for the Digital Portfolio leads regulatory strategy and execution for software-driven products, including software as a medical device (SaMD), software in a medical device (SiMD), cloud and connected applications, data and analytics tools, and AI/ML-enabled features that support surgical care. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Intuitive Surgical Inc

Senior Manager, Regulatory Affairs

With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.

Senior Regulatory Affairs Manager (Onsite)

This client-facing role supports labeling and Regulatory Operations activities throughout the product lifecycle, develops regulatory strategies, prepares and coordinates submissions, and supports compliant implementation and maintenance of approved labeling. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

Cencora, Inc.

Senior Manager, Regulatory Affairs - Animal Health Labeling

With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.

Regulatory Affairs Manager (Atlanta)

Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)

Brief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

Azurity Pharmaceuticals Inc

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.

Humacyte Inc

Director, Regulatory Affairs

Ensure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications. Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.

Kobayashi Healthcare International Inc

Regulatory Affairs Manager

Apply solid working knowledge of drug, biologic, and device development processes, laws, regulations, and guidelines from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and International Council for Harmonization (ICH). Demonstrate understanding of major regional and global industry association priorities, such as those of the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Japan Pharmaceutical Manufacturers Association (JPMA).

Parexel

Senior Regulatory Affairs Associate - Regulatory Intelligence

sourcestack_via_bold

They built the brand differently—online first, prioritizing direct relationships with customers—and in the process learned they’d created something bigger: a playbook and platform that could help other brands grow and scale to their full potential, and a vision to reimagine consumer packaged goods. Our beautiful 70,000 square foot SoHo office is decked out with bagels on Wednesdays and lunch on Thursdays, and fully stocked kitchens with snacks, coffee, and drinks everyday.

Mammoth Brands

Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence. Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.

Beeline Medicines

Senior Director, Regulatory Affairs CMC – Small Molecule

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

Regulatory Specialist Jobs in the United States

Product & Regulatory Specialist 1 Simmons Prepared Foods

Regulatory Compliance Specialist - Transplant Center Houston Methodist Hospital

Senior Specialist, Regulatory CMC Medexus Pharmaceuticals Inc

Respiratory Protection Regulatory Engagement Specialist 3M

Regulatory Operations Specialist Caldera Medical Inc

Manager, Quality Assurance & Regulatory Affairs RR Donnelley

Regulatory Affairs Manager - IVD CorDx

Senior Manager, Regulatory Affairs Intuitive Surgical Inc

Senior Regulatory Affairs Manager (Onsite) CorDx

Senior Manager, Regulatory Affairs - Animal Health Labeling Cencora, Inc.

Regulatory Affairs Manager (Atlanta) CorDx

Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDx

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals Inc

Director, Regulatory Affairs Humacyte Inc

Regulatory Affairs Manager Kobayashi Healthcare International Inc

Senior Regulatory Affairs Associate - Regulatory Intelligence Parexel

Regulatory Affairs Manager Mammoth Brands

Senior Director, Regulatory Affairs CMC – Small Molecule Beeline Medicines

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Senior Manager, Regulatory Affairs - Animal Health Labeling Cencora Inc

Similar Job Searches

See More Jobs

Stand out to leading employers.