Regulatory Specialist II

Abbott; South Portland (ME); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Job summary

Abbott in South Portland, ME is seeking a Regulatory Specialist II for a 12-month, on-site assignment. Responsibilities include technical writing for IVDR compliance, regulatory support for development and commercial products, and devising EU and international clearance strategies.

You will assist regional teams with submissions, renewals, and amendments, while maintaining existing approvals and licenses. The role requires a Bachelor's degree in a life sciences field and 4+ years in Regulatory

Qualifications

• Bachelor's degree in a life sciences or related field.
• 4+ years experience in Regulatory Affairs.
• Strong knowledge of IVDR and EU regulatory requirements.

Responsibilities

• Prepare technical writing for submissions in accordance with IVDR.
• Provide regulatory support for product development and commercial products.
• Develop regulatory strategies for EU and international clearance/approval.
• Support regional regulatory teams with submissions, renewals, and amendments.
• Maintain approvals and licenses for existing marketing authorizations.
• Assess regulatory impact of changes to products, manufacturing, and labeling.
• Develop internal procedures and tools and train stakeholders.

Skills

Regulatory writing

IVDR knowledge

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in sciences

Tools

Microsoft Office

Job description

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Researches and communicates scientific and regulatory information in order to write submission documents.
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Develops internal procedures and tools.
• Conducts informational or training sessions for stakeholders.
• Organizes and maintains hard copy and electronic department files.
• Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Title:

Regulatory Specialist II

Location: South Portland, ME

Duration: 12 Months

Shifts: 8AM TO 4:30PM

100% Onsite

Responsibilities

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Researches and communicates scientific and regulatory information in order to write submission documents.
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Develops internal procedures and tools.
• Conducts informational or training sessions for stakeholders.
• Organizes and maintains hard copy and electronic department files.
• Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Education

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
• 4+ years’ experience in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements is required.

Preferred Qualifications

• 1+ years’ experience in an IVD or medical device manufacturing environment.

Competencies

• Good knowledge of EU and international regulations.
• Demonstrated written and verbal communication skills.
• Strong time management skills, with the ability to work on multiple projects simultaneously.
• Ability to work independently as well as within a team.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.