Regulatory Affairs Specialist

September 17, 2024

Eurofins USA Clinical Diagnostics

Centennial

FULL TIME

Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description
Under the direction of the Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT’s laboratories are compliant with the regulatory and accrediting organizations that oversee our laboratories.
This position works closely and collaboratively with other functional areas throughout the network of laboratories.
The Regulatory Affairs Specialist shall:

Evaluates the regulatory environment and contributes to providing internal advice on regulatory and accrediting compliance.
Anticipates regulatory obstacles and emerging issues related to laboratory testing and the transplant industry/ community.
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes, as appropriate.
Provides regulatory information and guidance to the regulatory groups and others within the organization.
Identifies the need for new regulatory procedures, SOPs, and participates in development, training, and implementation of the regulatory processes.
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Assists other departments in the development of SOPs to ensure regulatory compliance, as needed.
Provides regulatory input and technical guidance on applicable international regulatory requirements.
Communicates and interacts with regulatory and/or accrediting authorities through appropriate communication tools.
Works with cross-functional teams for interactions with regulatory authorities.
Accountable for the organization, research, communication, maintenance, and growth of the DPT Regulatory Intelligence Library and addressing all regulatory inquiries in a timely manner.
Maintains list of all applicable Standards and Regulations which apply to all DPT facilities.
Maintains DPT regulatory licensing, certification and permits for all facilities including renewals, assay change notifications, site or lab director changes, etc. including updating and maintaining current regulatory status on websites (CAP.org, NYS HCS) and internal tracking spreadsheets (submissions, licenses/permits, etc.)
Manages and maintains industry standards and guidance subscriptions, maintains relationships with industry organizations and communicates any output to stakeholders.
Interprets and applies FDA and other industry regulations and standards to business practices and fit for purpose.
Writes, edits, and maintains departmental standard operating procedures with management and team.
Coordinates the internal Audit schedule and assign auditors as necessary to meet the scope and expectations of the schedule. Perform internal audits in auditor or lead auditor role.
Organizes and compiles information for inspection/audit responses.
Represents Eurofins DPT in lead or supporting role (e.g., host) for regulatory-based audits/inspections. Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews.
Maintains and utilizes working knowledge of applicable regulations, standards and policies; keep current with all relevant federal, state and local regulations and standards.
Performs duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions.

Qualifications
MINIMUM REQUIREMENTS

Bachelor’s degree (Life Science preferred)

WORK EXPERIENCE REQUIREMENTS

3+ years of quality, laboratory and/or regulatory experience in a regulated industry.
2+ years of experience with regulatory and/or accrediting agencies (i.e., FDA, ISO, ASHI, CMS-CLIA, etc.)
Ability to work effectively under the expectations of the Quality Management System.
Advanced analytical and problem solving skills.
Computer skills in Word, Excel and other Micro Soft applications. Database management and/or development skills helpful but not required.
Highly developed organizational and multitasking skills.
Possess a high level of integrity (professional, diplomatic, confidential) with demonstrated interpersonal skills and the ability to positively interface with employees and management.
High level skills in oral and written communications.
Willing to travel to satellite locations for quality support, internal audits, and regulatory inspections, as applicable (20% travel).
Quality Auditor Certification (ASQ or equivalent) desired.

POTENTIAL ENVIRONMENTAL FACTORS

This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
For a list of potential chemical hazards, see appropriate SDS sheet.

Additional Information
Compensation:

Salary: $70,000.00-$100,000.00

Schedule:

Monday-Friday

What we offer:

Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

We regret to inform you that this job opportunity is no longer available