REGULATORY COMPLIANCE SPECIALIST


Job Description


JOIN IN THE BATTLE AGAINST COVID-19

MPC has joined in the fight against Covid-19 and we are seeking out the most talented, reliable and personable individuals to join us in our fight. MPC is not a division of a major corporation. We are a very successful owner-operated, plastic injection molding company. Our maxim is: “Do unto others as you would have them do unto you.” In short, we treat all employees as family and we respect that each team member, regardless of his or her function or title is equally important to the overall success of the company. We are currently in the process of transforming our facility to help supply badly needed medical devices in the battle against Covid-19.

With a commitment to excellence, a thriving culture and by the implementation of leading technologies, Molded Precision Components has become a World-Class injection molding company. We specialize in design, tooling, automation, production of precision plastic components, and scientific injection moulding.

JOB PURPOSE:

The Regulatory Compliance Specialist will be integral to the overall success of MPC. In this role, you will ensure regulatory compliance at MPC by establishing compliance processes and preparing regulatory submissions for new and existing sites and products.

DUTIES &RESPONSIBILITIES:

  • Prepare regulatory submissions for site and product licensing as required by applicable US FDA and Health Canada regulations
  • Execute Regulatory Affairs projects that will ensure compliance with emerging regulatory requirements
  • Evaluate regulatory impact of proposed QMS, product, process and raw material changes
  • Regulatory approval of product labelling, accompanying documentation and marketing materials
  • Liaise with regulatory agencies as needed
  • Coordinate Post Market Surveillance and Annual Product Quality Review activities
  • Regulatory Affairs assessment of feedback, complaints and deviations to determine Mandatory Problem Reporting requirements
  • Liaise with a wide variety of functional areas to compile information required for regulatory submissions
  • Advise organization on changes to applicable regulations and standards and conduct gap assessments when needed
  • Lead the development and implementation of regulatory processes
  • Key personnel supporting external audits

QUALIFICATIONS:

  • Bachelor’s degree in a Science or Engineering discipline
  • Regulatory Affairs diploma or certificate considered an asset
  • 3-5 years experience in a Regulatory Affairs function within the Medical Device, Natural Health Product, Pharmaceutical or other relevant regulated industry
  • In-depth knowledge of US/Canada regulations, GxPs and Quality System Requirements pertaining to Medical Devices, Over-the-Counter Drugs and Natural Health Products
  • Excellent technical writing skills and attention to detail
  • Proactive, collaborative and solutions-oriented approach to investigating and resolving quality and compliance concerns
  • Excellent organizational and time management skills
  • Proficient in Microsoft Office applications including Excel, Work, Outlook, Powerpoint, Visio
  • Professional certification from Quality or Regulatory organizations i.e. ASQ, RAPS is considered an asset
  • Project Management experience or training is considered an asset

WHAT WE OFFER:

  • Our Culture, MPC provides a dynamic environment that challenges and rewards your technical skills. We are honoured to provide our valued Team Members with an environment where they can grow and thrive both professionally and personally. If you’re looking for a real career opportunity, this could be the place for you!
  • We have a real family-style atmosphere in our facility, and we love to have BBQ’s, golf tournaments, bike club and bowling (just to name a few!)
  • Career Development in a positive and enjoyable working environment
  • Medical benefits, Dental benefits, Vision care benefits and life insurance
  • Profit-Sharing
  • Access to our on-site fitness center
  • Free membership to Bliss Ann Green Yoga in Barrie
  • Clean, safe and stable working environment

WANT TO GET A BETTER LOOK AT MPC? CHECK OUT OUR WEBSITE AND OUR VIDEOS

VIDEOS SERIES: https://www.youtube.com/watch?v=TI9d4dWT7wU

MPC is committed to fair and accessible employment practices that attract and retain Associates with disabilities. This includes providing accessibility across all stages of the employment cycle. Accommodation is available upon request.