Product Material Compliance Specialist
Product Material Compliance Specialist
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Job Description
Southmedic is known globally as an innovative high quality Canadian medical device manufacturer. At Southmedic you will enjoy an openminded culture that fosters individual growth and career development within a dynamic team. Southmedic believes in continually investing in our staff; allowing you to reach your full potential through ongoing training and development. You will engage with a team that values respect accountability and integrity.
We are looking for a Product Material Compliance Specialist a skilled individual responsible forsupporting the maintenance and overall health of the Southmedic Material Compliance Program. This role will also provide compliance support to the Quality Engineering Document Control and Regulatory Affairs departments. The Product Material Compliance Specialist will lead the of compliance activities to support Southmedics proprietary medical devices distribution devices and contract manufactured product with a focus on material compliance. The role will also support regulatory activities.
What You Will Do
- Involved in all compliance activities associated with the Tier 1 Proprietary Products to ensure compliance with the regulatory requirements of Canada (Health Canada) US (FDA) Europe (MDR) and other international opportunities.
- Manage the Restricted Substances program. This shall include understanding continuous intelligence and actioning activities associated with the requirements of regulations which impact medical device material compliance and safety such as but not limited to REACH RoHS Prop 65 etc.
- Champion the Product material compliance program.
- Support compliance activities for distributed devices in the Canadian market.
- Support compliance activities for contract manufactured product under the direction of external parties relying on strong customer service skills.
- Support and champion the Quality Policy Manual (QPM) and the Quality Management System (QMS) through the maintenance and establishment of electronically controlled documents through the uniPoint software.
- Identify areas of opportunities within the Quality Management System (QMS) to support Southmedics key business objectives through the initiation of Corrective and Preventive Actions when appropriate.
- Take ownership of projects and work independently within a team environment to reach departmental and company goals.
- Communicate clearly effectively and professionally with customers registrars regulatory representatives suppliers and within the Southmedic team.
- Key support to External Customer and Regulatory audits.
- All other projects and duties as assigned.
What We Need
- Bachelor of Science or Engineering or postgraduate education in a Compliance Quality Assurance or Regulatory discipline
- Minimum 1 year experience in material compliance and familiarity with restricted substance regulations that impact medical devices such as REACH RoHS Prop 65 etc. Familiarity with plastic material compliance is required.
- Experience in sustainability or environmental quality systems such as ISO 14001 is an asset.
- Experience working within a Quality Management System including ISO 9001 ISO 13485 and within a regulated manufacturing environment
- Experience in regulatory affairs customer service root cause analysis meeting management time management and technical writing
- Strong background in GMPs EU MDD/MDR MDSAP and FDA Part 820 requirements would be considered an asset.
- Experience or training in auditing would be considered an asset.
What We Offer
- Competitive base salarywith performancebased bonuses and incentives.
- Mileage & Expenses Reimbursement for business related travel.
- Retirement Program Southmedic will match RRSP contributions in our program that employees can begin participating on their first day.
- Benefits Our group benefit plan covers medical dental vision and other health needs including our employee assistance program.
- Perks Southmedic employees enjoy a variety of perks and discounts from local corporate partners like fitness memberships events and more!
- Education Reimbursement Our continuing education program provides financial assistance for training and education courses.
- Engagement We hold a number of social activities during the year including BBQs giveaways and employee activities.
Southmedicis committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process please advise the Human Resources Department.
We thank you for your interest in joining the Southmedic Team!
#SM
Required Experience:
Unclear Seniority
Employment Type
Full-Time
