Reference Number: JO-2106-471125
Job Type: Permanent
Location: Newcastle Upon Tyne
100% work from home
In this position, you’ll be responsible for regulatory strategy development and execution for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior RA Specialist/Principal will collaborate cross-functionally and with business partners on new product development and critical initiatives to own the regulatory activities for global commercialization. The incumbent can innovate, communicate and execute strategic regulatory plans, get results independently in a matrix team environment, and is able to solve sophisticated problems to meet business obligations timely.
What you’ll be doing:
Serve as Regulatory Affairs representative on new product development teams and partnership programs.
Collaborate globally and cross-functionally (e.g., Global Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to define regulatory strategy and plans for clearance/approval of technologies intended for cancer diagnostics in the anatomic pathology, IVD and Companion Diagnostics markets.
Provide regulatory input to support program prioritisation including resource requirements and timeline.
Define and progress requirements to meet targeted claims and align with partners and stakeholders on study designs.
Align with partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
Author and maintain regulatory submissions including defining the global regulatory requirements, crafting standard work and action plans, optimizing timelines, articulating submission content and format and developing countermeasures as plans evolve.
Communicate and negotiate with global regulatory agencies to meet business goals and regulatory achievements for product commercialization.
Keep up to date of new and evolving regulatory intelligence and maintain proven understanding of relevant regulations, mentorship, requirements and driven products that affect the business; provide interpretation and education to internal and external partners.
Share information and experience across LBS and Danaher sites; serves as representative on taskforces, councils or improvement initiatives.
Integrates DBS principles and practices including leading continuous improvement initiatives, solving sophisticated problems and driving for measurable results.
A successful candidate will possess:
Bachelors degree in science or engineering or equivalent experience.
Must have requisite training in IVD or medical device Regulatory Affairs through on-the-job training, seminars or certification.
Progressive experience in support of New Product Development for high complexity products. Experience supporting clinical trials a plus.
Proven experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market.
Experience in the IVD, Companion Diagnostics and/or stand-alone software/digital fields preferred.
Ability to apply practical experience and knowledge of regulatory affairs to the development and commercialization of sophisticated, high-risk products for a global market.