Top 12 Regulatory affairs Jobs in Victor, Ny

Senior Specialist, Global Regulatory Systems
CooperVision —Victor, NY
- $91,928 - $122,570 a year
- Full-time
- Microsoft Excel
- English
- Office
Scientist I
Bausch + Lomb —Rochester, NY
- $60,000 - $85,000 a year
- Mid-level
- Bachelor's degree
- US work authorization
- Paid holidays
- Disability insurance
Sr. Reg Affairs & Compl Spec
University of Rochester —Rochester, NY
- $70,600 - $105,800 a year
- Full-time
- Surgery
- OSHA
- 5 years
Medical Affairs Director
LSI Solutions Inc —Victor, NY
- $150,000 - $220,000 a year
- Extended hours
- Microsoft Word
- Medicine
- Surgery
- Paid holidays
- Health insurance
Quick Apply
Senior Director, Scientific Affairs
ACM Medical Labs, Inc —Rochester, NY
- $175,000 - $240,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Bachelor's degree
- Relocation assistance
Quick Apply
Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island
Vertex Pharmaceuticals —United States
- $171,300 - $256,900 a year
- Full-time
- English
- Mentoring
- Data entry
- Loan repayment program
- Health insurance
Head of Clinical Operations (Oncology)
Kaztronix —United States
- Remote
- 11+ years
- Business development
- Bachelor's degree
Quick Apply

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regulatory affairs jobs near victor, ny

Senior Specialist, Global Regulatory Systems

CooperVision -
Victor, NY

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Job Details

Full-time
$91,928 - $122,570 a year

Qualifications

Bachelor's degree

Full Job Description

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com .

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).

Representative for the Global Regulatory Systems team. Provides leadership, project management, and training support to Regulatory Affairs (RA) and cross-functional teams. Supports implementation, adoption, and use of systems enabling global and regional regulatory activities. Partners with Regulatory, Quality, Supply Chain, Marketing, Legal, Operations, Clinical, Medical, R&D, and IT to ensure documentation required for global product registrations is available. Provides system training and develops supporting materials (e.g., work instructions, training documentation). Operates in alignment with the RA mission: PROTECT the business and freedom to operate GROW the business and customer value

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

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.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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

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Refine Your Search

regulatory affairs jobs in victor, ny

Senior Specialist, Global Regulatory Systems

Scientist I

Sr. Reg Affairs & Compl Spec

Medical Affairs Director

Senior Director, Scientific Affairs

Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island

Head of Clinical Operations (Oncology)

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