Job Description

Join a Scaling-up Medical Device Company based in Greater Vancouver and Lead their Clinical and Regulatory Strategy and Design

TalentSphere Staffing Solutions is partnered with a growing and cutting-edge life sciences company in the Greater Vancouver region focused on developing and commercializing products to transform health management. As a Director of Clinical Regulatory Affairs with a strong clinical trials and regulatory affairs background, you will play a pivotal role in ensuring their products gain necessary approvals in international markets, including the USA, Canada, Europe, Asia, and beyond.

You are a can-do, positive attitude supportive leader, who embraces a culture of growth and change and thrives in a rapidly changing environment. Work with dedicated scientific minds with Greater Vancouver IVD company scaling up. Make your mark and provide direction to their global strategy in this full-time role.

Responsibilities

We are seeking a forward-thinking and experienced Director of Clinical Regulatory Affairs to develop and execute clinical and regulatory strategy and design. You are a seasoned director of both clinical and regulatory planning and implementation who will lead a growing team.
Working closely with the product development and QA&C teams, you will spearhead and lead:

• Clinical Strategy and Design - lead protocol and implementation documentation, patient population and advocacy groups and clinical trial budget design.
• Regulatory Strategy and Design - lead regulatory strategy and navigate the international regulatory landscape and requirements to gain product approvals in key markets including all regulatory submission and intelligence for compliance.

Required Qualifications - Do you Meet These?

• PhD in immunology or a related life sciences field.
• Minimum of 7+ years of experience in Clinical Regulatory Affairs within the IVD industry.
• Director level experience in current roles.
• Proven track record of leading clinical trial strategy and design.
• Proven track record of multiple product approvals in the US and global jurisdictions.
• Established network of contacts and relationships with CROs, CMOs and regulatory bodies.
• Experience with early and late stage IVD development and validation and regulatory approval process.
• In-depth demonstration and knowledge of developing medical device and IVD regulatory strategy, standards and other activities.
• Experience preparing and accomplishing complex submissions to global regulatory agencies.
• Expert analytical and problem-solving abilities thriving in a rapidly evolving environment.
• Exceptional leadership skills, excellent communication and interpersonal skills.

Salary Range $100,000 - $135,000 commensurate with experience and a bonus plan.

What\'s in it for you?

This is an opportunity to develop your career with a highly respected growing industry leader. A culture that places an emphasis on teamwork, inclusiveness and tenacious to see results in their work and health outcomes.

Only candidates legally entitled to work in Canada will be considered.

Benefits:

• Casual dress
• Proximity to SkyTrain and bike routes
• Free parking near by
• Company events
• Extended Healthcare
• Flexible schedule
• On-site gym

TSSHP
LI-TS1
(#16322647)

TalentSphere