Regulatory Affairs Specialist

Job#: 2028119

Job Description:

Regulatory Affairs Specialist

Apex Systems is searching for a Regulatory Affairs Specialist for our client in Mississauga, ON. Our client is in the Medical Device industry and is looking for someone with a background in medical device regulatory affairs, and experience with ISO 13485 & 14971, regulatory affairs submission in both Canada and the US, technical writing skills, and knowledge of GMP . This position is a rolling 12-month contract opportunity working on the day shift, with possibility of extension or a full-time job offer.

Client: Medical Device Manufacturer

Contract: 12-month contract (possibility for extension/conversion)

Location: Mississauga, ON (3 days/week onsite work required)

Application Process: Please apply via the medium on which you are seeing this posting. If you encounter technical difficulties submitting your resume, please send a Word version of your resume to Phil at [email protected]. Please reference Job Title Regulatory Affairs Specialist

Responsibilities:

  • Assist with strategy, planning, preparation and submission of medical device license/ registration applications to Health Canada, FDA, and rest of the world countries.
  • Work closely with the supervisor, local regulatory representatives, and distributors to compile regulatory submissions and efficiently respond to review queries from global regulatory agencies.
  • Maintain and update registrations and licenses as required. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, notification of changes and annual updates.
  • Ensure accurate and timely submissions to regulatory agencies.
  • Maintain current knowledge of international regulations, guidance and standards applicable to our clients products and ensure compliance.
  • Research regulatory issues and disseminate regulatory information to Production, QA/QC, and R&D departments and senior management.
  • Assist with regulatory compliance activities such as labeling reviews, post-market reports and clinical evaluation reports.
  • Maintain internal and external regulatory documentation database.
  • Work with cross-functional teams and interface with manufacturing, R&D and quality representatives to provide regulatory assessment and support for new development projects and proposed changes to products and processes, as required.
  • Coordinate activities related to notarization, legalization and authentication of documentation required for regulatory filing.
  • Prepare Regulatory Working Instructions/Flow Processes/Procedures, as required.
  • Ensure all work is in compliance with applicable company standard, ISO standards, GLP, GMP and GCP and established SOPs.
  • Reporting immediately to immediate manager, any variances from the target completion date of the tasks, or that the tasks cannot be completed.
  • Working effectively in collaboration with other members of the department, or with managers and staff across the organization with whom tasks must be completed.
  • Working in a safe manner so as not to endanger individual health and safety, or the health and safety of others.
  • Working to achieve assigned tasks within the standards required (quality, quantity, time and resources).
  • Complying with all legal requirements, all corporate policies and procedures, and with generally accepted business and ethical practices.
  • Performing other duties as assigned by immediate manager.

Key Qualifications: 
  • 2+ years of experience in Regulatory Affairs at a medical device or biomedical company.
  • Specific experience with FDA requirements, guidance documents, 510(k) submissions, ISO 14971 and ISO 13485.
  • Post-graduate certificate in a related Regulatory Affairs course is an asset.
  • Strong organizational skills and timeline management.
  • Ability to manage multiple projects, work independently, and flex with changing priorities.
  • Experience with negotiations/ interactions with regulatory agencies.
  • Excellent analytical thinking and problem-solving skills.
  • Demonstrated ability to influence based on experience, facts, and data.
  • Advanced computer skills, e.g., proficient in the Microsoft suite (WORD [create and use templates], EXCEL, and PowerPoint), Adobe Acrobat.

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Employee Type:
Contract

Location:
Mississauga, ON, CA

Job Type:

Date Posted:
May 6, 2024