Senior Specialist, Global Regulatory Systems

CooperCompanies • $91K — $122K *
Victor, NY 14564In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • 5+ years in a medical device or pharmaceutical regulatory environment
  • Bachelor's degree in a scientific or technical field
  • Advanced degree or Regulatory Affairs Certification preferred
  • Familiarity with global regulatory requirements (FDA, ISO, MDSAP, Health Canada, LATAM)
  • Hands-on experience with regulatory systems like Veeva Vault RIM
  • Strong communication skills, both written and verbal
  • Proficiency in Microsoft Office and Adobe Acrobat

Responsibilities

  • Support implementation and improvement of regulatory systems and processes
  • Serve as Veeva Vault RIM Business Administrator in coordination with IT
  • Provide user support, training, and change management
  • Develop and track system performance metrics
  • Assist with regulatory documentation preparation and submission for assigned markets

Benefits

  • Up to 10% travel for domestic or international opportunities
  • Office-based work with a collaborative environment
  • Engagement with multiple regional RA teams for enhanced professional growth
  • Potential for process improvement initiatives and career development opportunities
  • Learning and training support for ongoing education in regulatory affairs
Full Job Description
Job Description

Job Summary:
Supports RA teams in the use of regulatory systems, including Veeva Vault RIM, to enable global product registrations and regulatory activities. Ensures consistent system utilization, resolves user issues, and supports integration with other systems (e.g., eQMS, Agile).

Responsibilities

Essential Functions & Accountabilities:

Supporting RIM or other systems:
  • Support implementation and improvement of regulatory systems and processes, including:
    • Veeva Vault RIM (communication, adoption, roadmap support, best practices)
    • Acts as the Change Agent providing Technical documentation for submissions
    • Source of Truth (SOT) data management
    • Unique Device Identification (UDI)
  • Serve as Veeva Vault RIM Business Administrator in coordination with IT
  • Provide user support, training, and change management
  • Partner with regional RA teams to identify and implement system improvements
  • Support system integration with platforms such as eQMS
  • Ensure required documentation is available within systems and aligned with QMS
  • Liaises with other, non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end users
  • Monitor system usage and support global registration activities
  • Develop and track system performance metrics
  • Investigate and resolve system-related issues using QMS processes
  • Maintain audit-ready documentation

Registration Activity - supporting regional RA activities:
  • Assist with preparation and submission of regulatory documentation for assigned markets
  • Collaborate with agencies, consultants, and partners to ensure complete and accurate submissions
    May assist with preparation, compilation, and submitting regulatory documents for the registration of current and new products in assigned markets, as agreed with regional RA leadership.

Monitoring Registration Requirements:
  • Identify regulatory requirements with regional RA representatives
  • Maintain knowledge of applicable regulations and standards
  • Communicate regulatory requirements and assess impact of changes

Support to CooperVision Processes:
  • Represent regulatory perspective across the organization
  • Provide guidance on regulatory and quality matters to minimize risk and improve outcomes
  • Deliver training and support
  • Other duties as assigned

Travel:
  • Up to 10% domestic or international travel


Qualifications

Knowledge, Skills and Abilities:
  • 5+ years in medical device or pharmaceutical regulatory environment (preferred)
  • Bachelor's degree in scientific or technical field required
  • Advanced degree or Regulatory Affairs Certification preferred
  • Knowledge of global regulatory requirements (FDA, ISO, MDSAP, Health Canada, LATAM)
  • Experience with regulatory systems (e.g., Veeva Vault RIM)
  • Experience in technical documentation and document management systems
  • Strong written and verbal communication skills
  • Experience interpreting regulations and international standards
  • Process improvement experience within regulatory or quality systems
  • Experience with change control and change management
  • Strong project management, technical writing, analytical, and problem-solving skills
  • Independent self-starter; manages time effectively
  • High attention to detail and organization
  • Ability to work independently and across global teams including adjust work schedule to adapt to different time zones, as needed.
  • Knowledge of medical device regulations required; or ISO standards preferred
  • Veeva Vault Business certification (or ability to obtain)
  • Proficient in Microsoft Office (Excel, Project, Visio) and Adobe Acrobat
  • Fluent in English

Work Environment:
  • Office-based with extended computer use
  • Onsite 5- days a week in office

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $91,928.00 and $122,570.00 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

About CooperCompanies

CooperCompanies Careers

Joining CooperCompanies presents an unparalleled opportunity to become part of a global team dedicated to fostering innovation, leadership, and professional growth. As a leading entity in the medical sector, CooperCompanies offers a range of job opportunities that cater to a diverse set of skills and experiences.

Explore Career Opportunities

CooperCompanies is actively hiring and continuously seeks passionate, creative, and solution-driven team players. Explore open positions that align with your professional interests and expertise. Each position at CooperCompanies is a chance to thrive in a culture that values diversity and leadership.

Professional Growth and Development

At CooperCompanies, career growth is a priority. The company supports professional development through comprehensive training programs, including leadership development and diversity training. These initiatives ensure that every team member has the tools and knowledge to advance their career.

Innovation and Team Collaboration

Innovation is at the heart of CooperCompanies. The team collaborates on projects that push the boundaries of technology and service in the medical field. Working at CooperCompanies means joining forces with some of the brightest minds in the industry to deliver solutions that truly make a difference.

Internship Programs

For those starting their career journey, CooperCompanies offers internship programs that provide a robust introduction to the medical industry. Internships are a pivotal step for gaining real-world experience, enhancing your resume, and building a professional network.

Benefits and Company Culture

CooperCompanies is committed to supporting its employees with exceptional benefits and a nurturing work environment that promotes a balance of professional and personal growth. The company culture is built on a foundation of respect, inclusion, and collaboration, making it a prime workplace for individuals from all walks of life.

Networking and Industry Leadership

Employees at CooperCompanies are encouraged to engage in networking opportunities within and beyond the company. This connectivity is vital for fostering relationships that can lead to innovative collaborations and career advancement.

Applying for a Position

To apply for a position at CooperCompanies, candidates should prepare their resume to highlight relevant experience and skills. The interview process is designed to assess fit both for the candidate and the company, ensuring alignment with CooperCompanies' core values and business objectives.

Stay Connected with CooperCompanies Careers

Keep up to date with the latest job opportunities, company news, and industry insights by subscribing to the CooperCompanies careers newsletter. Discover the exciting and rewarding career opportunities that await at CooperCompanies.

Search CooperCompanies Jobs

Interested candidates are invited to search current job listings and find positions that match their skills and career aspirations. Join CooperCompanies and be part of a team that is dedicated to making a significant impact in the healthcare industry.
Learn more about CooperCompanies
Industry
Healthcare
* Ladders Estimates

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