2,816 Regulatory Affairs Specialist jobs in the United States

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.

The Regulatory Affairs Specialist supports our product teams supporting new product development and lifecycle management. This position is responsible for supporting the product development and regulatory submissions for in vitro diagnostic devices containing both software and chemistry. This is a role that would suit an individual interested in developing a career as a regulatory professional and who has interest in supporting the development of in vitro diagnostics in the US or international regulatory space. This is a full-time position working standard business hours but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Senior Manager of Regulatory Affairs.

Support the preparation, submission, and maintenance of electronic/paper regulatory submissions according to applicable regulatory requirements and guidelines.

Support the development and maintenance of technical files for In Vitro Diagnostic devices per local and global regulations.

Provide regulatory input and guidance on US and global regulatory requirements throughout product development for in vitro diagnostics devices.

Support cross-functional team in the application of relevant regulations and standards (e.g., IEC 62304, ISO 14971, ISO 13485).

Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are integrated into the product development process.

Evaluate updated regulatory requirements and help implement necessary adjustments to maintain compliance.

Assess the acceptability of documents and product development activities for submission filing to comply with applicable regulations.

Conduct gap analyses and audits to identify areas of non-compliance and recommend corrective actions.

Support medical device reporting, post-market surveillance, and vigilance reporting per the regulations.

Work closely with other Regulatory Affairs team members to develop processes and implement compliance standards as required by local/international regulatory requirements.

Monitor and track the status of regulatory activities/projects and provide updates to leadership as needed.

Bachelor's degree or equivalent, preferred.

Excellent technical writing skills.

Strong analytical skills, attention to detail, and the ability to interpret and apply regulatory requirements.

Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment.

Familiarity with medical device regulatory pathways and requirements.

Ability to work independently on unfamiliar tasks or projects when necessary.

Ability to understand and apply international standards relevant to in vitro diagnostics.

Proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.

Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota. Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

This role is hiring at an annual salary of $78,000 - $85,000 and is eligible for bonus and equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

The application deadline for this position is July 30, 2025.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

On-Board Scientific is hiring a Regulatory Affairs Specialist in
West Lake, OH  
For immediate consideration please send your resume to

• Classify new and existing products according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, including compliance with local regulations such as:
  • U.S. Hazard Communication Standard (HazCom 2012)
  • Canadian WHMIS 2015
• Pre-author Safety Data Sheets (SDS) and labels in accordance with HazCom 2012 and WHMIS 2015
• Support regulatory projects and change management processes
• Respond to basic customer regulatory queries 

• Bachelor’s degree in Chemistry, Biology, Toxicology, or a related field
• Experience in a professional-level role, preferably within a business or regulatory environment
• Familiarity with OSHA, TSCA, RCRA, and Export regulations is desirable
• Background in Industrial Chemical Regulatory Affairs is preferred
• Strong ability to manage multiple projects and effectively communicate progress to senior staff
• Excellent written and verbal communication skills
• Proficient computer skills; experience with SAP is preferred

 
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Join to apply for the Regulatory Affairs Specialist role at Katalyst CRO

Join to apply for the Regulatory Affairs Specialist role at Katalyst CRO

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• The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
• This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
• This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations.
• They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows.
• They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site.
• Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
• Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
  
  

• The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
• This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
• This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations.
• They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows.
• They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site.
• Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
• Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
  
  

• BS required in Life Science discipline or engineering.
• Experience working with GXP integrated commissioning and qualification practices
• Experience working within a regulated environment.
• Experience with coordinating invasive operations from managing large capital projects/investments.
• Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
• Clear operational experience in R&D and development laboratories.
• Excellent communication and technical writing skills.
• Demonstrated problem solving / trouble shooting skills.
• Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc
• Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday.
• Ability to grow and gain entry to laboratory, manufacturing, and mechanical areas.

• Seniority level Mid-Senior level

• Employment type Contract

• Job function Legal
• Industries Pharmaceutical Manufacturing

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Regulatory Affairs Specialist

Bridgeport CT

$100,000.00 - $125,000+ Bonus + Paid Relocation

This position will manage all regulatory affairs activities for categories in the US.

This includes:

• Labeling, product development compliance, package development, SDS and ingredients statement generation, customer and regulatory compliance needs, consumer regulatory inquiries, and the safety and efficacy of ingredients.
• Partner with key stakeholders, including but not limited to Marketing, Legal and Product Development, and provide regulatory input in support of product development, ensuring regulatory requirements are communicated and elevated, where appropriate.
• Support QA and Manufacturing related to inspections, recalls and product reviews by regulatory agencies.
• Develop processes/procedures as necessary to support regulatory compliance.
• Prepare and present presentations, both written and oral, to various levels of management.
• Stay abreast of new regulatory developments and communicate relevance to the business.
• Stay abreast of advancements in toxicology research and contribute to the development of safer and more sustainable products.
• Manage workload and prioritize tasks.
• It is anticipated that this role will transfer to First Quality approximately Q4 2025.

• 10+ years' experience in regulatory affairs.
• Bachelors or Graduate degree in a science related field, law or regulatory science, business administration or public health preferred.
• Strong communication skills
• Ability to manage projects across various departments and teams.
• SAP experience preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams)
• Strong team player with the ability to collaborate effectively across cross-functional stakeholders

• Health Insurance: affordable plans for medical, dental, vision and wellbeing starting on day 1
• Work-Life Balance: Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
• Financial: 401k matching, employee share plan with voluntary investment and the company's matching shares, annual performance bonus, service awards and student loan reimbursement
• Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
• Career Growth: diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement

18 hours ago Be among the first 25 applicants

• Preparing documentation for international regulatory registrations.
• Preparing technical documentation to compliant to MDD and EU MDR.
• Defining worldwide regulatory requirements are necessary for regulatory approval of products.
• Participating in cross functional teams as regulatory lead.
• Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
• Authoring submissions, researching requirements, setting priorities, and maintaining project schedules.
• Providing guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations.
• Executing on additional responsibilities as defined by management.
• Act as a Subject Matter Expert (SME) to support internal and external audits.
  
  

• Preparing documentation for international regulatory registrations.
• Preparing technical documentation to compliant to MDD and EU MDR.
• Defining worldwide regulatory requirements are necessary for regulatory approval of products.
• Participating in cross functional teams as regulatory lead.
• Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
• Authoring submissions, researching requirements, setting priorities, and maintaining project schedules.
• Providing guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations.
• Executing on additional responsibilities as defined by management.
• Act as a Subject Matter Expert (SME) to support internal and external audits.
  
  

• Bachelor's degree in science, Engineering, or other relevant discipline.
• Minimum 5-8 years' experience in Regulatory Affairs in the medical device industry.
• FDA, EU, Health Canada, and international registrations experience.
• Working knowledge with quality system regulations and guidelines.
• Ability to develop clear, concise, and timely oral and written reports.
• Great communication skills with all levels of personnel.
• High level of organization and planning skills.
• Working knowledge of medical devices, procedures, and terminology.
• Drug-combination experience a plus.
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Legal
• Industries Business Consulting and Services

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