Sally Prawdzik Email & Phone Number

Vancouver, British Columbia, Canada

Vancouver, British Columbia, Canada

Responsible for leading a policy team focused on medical device international policy and programs.

Vancouver, Canada Area

Sr. Advisor in Health Canada's Regulatory Innovation Team - advancing regulatory policy solutions to support health product innovation in Canada and enabling Canadians' access to promising new therapies

Vancouver, Canada

Engaged with internal and external stakeholders, including international regulators and global trade associations, to understand emerging regulatory issues, communicate business impact and drive efforts toward sustainable, globally harmonized approaches to device regulation. • Analyzed and conveyed relevant regulatory intelligence to regulatory teams and senior leadership, enabling effective regulatory strategy development. • Implemented proactive advocacy strategies that shaped health authority regulations and guidance in line with company priorities. • Recognized as a regulatory thought leader; appointed Industry Chair of the Medtech Canada Regulatory Committee (2018). • Played leadership role in driving global regulatory harmonization by leveraging strong health authority relationships and active engagement in global trade association discussions. • Actively connected with business unit teams to quickly understand new device product areas including sterilization equipment, cardiac ablation devices, imaging software and high-risk implants, in order to provide relevant strategic policy advice. .

Vancouver, Canada

Key Accomplishments:Strong relationships with Health Canada coupled with strategic thinking led to fast submission approval times, including fastest company approval time on record for an Class III IVD submission. Co-led successful Global Regulatory team re-structure when WW RA Director role was vacant, and successfully managed significant additional responsibilities of the US RA Director role for 1 year until position was filled. Responsibilities:•Leading Canada regulatory team•Leading the global regulatory copy clearance team for the Diabetes Franchise •Leading US regulatory policy shaping for the Diabetes Franchise •Co-chairing multiple regulatory sub-committees at Medtech Canada device trade association•Interim Director, Regulatory Director for insulin delivery & digital solution platforms, including leading global regulatory team, developing global regulatory strategies and managing US and EU submissions

Vancouver, Canada

Key Accomplishments:Led multiple face to face health authority pre-submission meetings to shape submission strategies. Seized opportunity to lead a trade association sub-committee to increase influence on shaping Health Canada policy. Successfully led regulatory due diligence activities to assess a global device partnership including assessing company regulatory competence, developing global regulatory strategy scenarios and working with the cross functional team on the new commercial structure. Developed training and invited to present to Health Canada staff to educate on medical device development and human factors. Submitted new Health Canada Class III insulin infusion pump within two weeks of PMA submission and received approval faster than average approval time, with no technical review questions.Responsibilities:•Leading Canada regulatory and quality team•Partnering with commercial team to develop new product launch strategies•Influencing regulatory policy by interfacing with Health Canada and industry associations•Overseeing quality systems team including management of recalls, audits and adverse event reporting•Site lead for health authority inspections•Leading site management review process

Vancouver, Canada

Key Accomplishments:Developed strong relationships with the commercial organization and provided strategic promotional material reviews to maintain compliance while meeting business objectives. Successfully implemented new CAPA system at the Canada facility, including liaising with global affiliates as well as developing and executing the local training program. Participated in MD&D CAPA team to develop global CAPA standard and presented team findings at global J&J CAPA forum. Responsibilities:•Development of device submissions •Partnering with commercial team to develop new product launch strategies•Creation of SOPs and WIs•Managing CAPA & NC system•Supporting health authority inspections•Promotional material reviews•Leading recall execution •Providing regulatory & quality systems training for all employees

Charlottetown, Pei

Responsibilities•Preparation of OTC pharmaceutical submissions •Creation of SOPs and master documents•Overseeing contract R&D company•Approval of packaging and printed materials•Implementation of GMP training program •Relations with regulatory officialsHosting GMP auditors•GMP compliance audit readiness•Executing validation protocols•Regulatory advisor to other departments

Calgary, Ab

Responsibilities•Managing new product development •Creating product nutritional profiles •Investigating customer complaints •Corresponding with contract companies•Reverse-engineering formulas•Responding to product technical questions

Bachelor Of Science (B.Sc.), Zoology/Animal Biology

Bachelor Of Science (B.Sc.), Physical And Biological Anthropology, Honours