Senior Regulatory Affairs Specialist Job Listing at Kelly Services in Toronto, ON (Job ID CA3607005_BH9944346)

Description

Kelly FSP is hiring for a Senior Regulatory Affairs Specialist with our Medical Device Client in Markham, ON.

This is a hybrid position (3 days a week in office)

 

Senior Regulatory Affairs Specialist

As a member of our Regulatory team, you will proactively drive launch of new products in markets/geographies through Regulatory expertise and support marketing and product development initiatives by providing strategic global regulatory guidance.

Provide accurate, relevant, and timely information internally and externally, to maintain product regulatory compliance, and to support approval of regulatory submissions for global product markets.

Responsibilities Include:

1. Strategy
2. Develop international strategies for regulatory approval of medical devices through regulatory/product competitive research and insights
3. Drive clarity on risks and methods to overcome them to have market centric products in the shortest possible time.

Regulatory Submissions

Lead regulatory submissions, including filing and/or creation of Dossiers, 510(k) Submissions, Applications, Change Notifications, and other country-specific product registrations

Prepare robust regulatory applications with right claims to achieve high yield with strategy to accelerate product launch success.

Regulatory Approval Maintenance

Maintain ongoing surveillance, analysis, and dissemination of all relevant international medical device regulations to ensure regulatory compliance is maintained and internal parties are appropriately informed.

Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed

Complete annual renewals and international registration updates as necessary

Evaluate impact of changes on regulatory compliance.

Evaluate temporary deviations and nonconformance reports for Adverse Effects and regulatory compliance

Support regulatory and customer audits.

Relationship Management

Interface with regulatory agencies as the need arises and build strong relationships Provide the voice of international regulatory affairs on project planning and cross-functional project teams and drive clarity for market access in the shortest time period with claims strategy.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Support regulatory, customer and internal audits.

Post Market Surveillance Activities

Act as Post Market Surveillance (PMS) Agent for specific product lines

Review Customer Feedback within established timeframes for reportability

Approve Complaint Closure Reports

Report trends from product feedback to support continuous improvement, vigilance activities and management reviews

Actively participate in annual Post Market Surveillance meetings

Perform appropriate Vigilance Activities (reports, advisory notices, etc.)

Compliance

Comply with Company policies, operating procedures, and processes

Health and Safety

Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

QUALIFICATIONS

1. Bachelor's Degree in health or biological sciences, or a related field
2. Certificate in Regulatory Affairs or equivalent work experience
3. 10 years of regulatory experience in a medical device environment within Health Canada
4. Must have familiarity with current Canadian regulations
5. Developed strategies and documentation to support submissions and approval of medical device applications globally, specifically within Canada
6. Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset
7. Knowledge of the requirements of an ISO 13485 quality program
8. Excellent oral and written communication skills, including technical writing.
9. Computer literate with:
10. Advanced experience in a Windows environment
11. Advanced experience in MS Word
12. Advanced experience in MS Excel
13. Experience using database software to manage data and records is an asset.
14. Strong organizational and general administrative skills
15. Demonstrated attention to detail.
16. Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g., customers

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing a workplace environment that is inclusive and respects the dignity of those in our workforce. Consistent with that commitment, Kelly will ensure that persons who are otherwise able to work are not unfairly excluded from doing so based upon any grounds protected by applicable human rights legislation, and will make all reasonable efforts to accommodate the needs of applicants and employees in all employment processes including but not limited to, hiring, advancement, discharge, compensation, or training.

 Apply on company website