Regulatory Affairs Manager jobs in Lewiston, ME

Position Title: Quality Assurance/Regulatory Affairs Specialist II

Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a small, growing company that offers a relaxed but challenging work environment.

BENEFITS:

• Medical insurance
• Dental insurance
• 401(k)
• Profit sharing plan
• Vacation
• Holidays
• Sick leave

Please apply through Email/ No Phone inquiries accepted at this time.

GENERAL SUMMARY:

The Quality Assurance/Regulatory Affairs (QA/RA) Specialist II is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. Under the supervision of the Manager of QA/RA, the QA/RA Specialist II is responsible for implementation, management, and maintenance of policies, procedures, and systems that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820, ISO 13485, and IVDR. The successful candidate has a strong in vitro laboratory diagnostic industry background and is experienced in global regulatory submissions, and registrations. It is expected that the QA/RA Specialist II will rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Maintains MMQCI’s ISO 13485 certification and prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
• Prepares and submits FDA pre-submissions, and 510(k) submissions and maintains appropriate FDA registrations.
• Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development, manufacturing, and/or marketing.
• Remains current on regulatory issues/trends affecting MMQCI products, assessing and communicating their impact to QA/RA colleagues and support teams.
• Provides training or presentations to cross-functional groups on a variety of regulatory topics.
• Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs). Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
• Participates in, and may conduct, internal, customer, FDA, and ISO audits.
• MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
• Writes SOPs and trains key personnel as needed.
• Performs other duties as assigned.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

• Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.
• Excellent proof-reading skills are required.
• Knowledge of current GMP regulation, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is required.
• Experience in laboratory medicine is highly preferred.
• Good communication skills, written and oral, with excellent computer skills. Strong work ethic with the ability to work in a dynamic environment with changing priorities.
• Ability to meet challenging timelines, in spite of obstacles.
• Willingness to learn and pitch in as part of team
• Ability to communicate clearly and constructively to correct non-conforming behaviors and practices.
• Must be a nonsmoker due to product contamination prevention requirements.

A cover letter is required.

Contact Information:

Human Resources

Maine Molecular Quality Controls, Inc.

23 Mill Brook Road

Saco, Maine 04072

LOCATION: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility located in Saco, right next to the Eastern Trail. Come join us!

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Parental leave

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Laboratory: 1 year (Preferred)
• Quality Assurance: 2 years (Required)
• cGMP: 5 years (Required)
• IVDR: 1 year (Required)

Work Location: In person