Senior Regulatory Affairs Specialist
1 day left
- Experience Level
We are seeking a multifaceted and experienced Senior RA professional to join our growing team.
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 Leica Biosystems 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:
- Bachelor’s 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.
- Skilled at leading teams in a matrix environment to achieve decisions, results and issue resolution in a timely manner.
- Understands regulatory impacts to the business to analyze global problems and project impacts.
- Models agility in changing strategies and prioritisation in the face of new information.
- Sets and communicates high expectations for self and the organization and leads by personal example.
- Demonstrates strong communication skills Ability to explain difficult or critical information to an audience with varied knowledge and experience. Works to build consensus.
- Ability to assess and communicate options and strategic risks/benefits. Is not afraid to take a tough position; acts as a role model for facing problems head-on, making difficult decisions, and taking ownership for them.
Interested? Join the Leica Biosystems Team!
Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We truly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to build and provide an environment that offers exciting, stimulating, and financially rewarding opportunities. As a Leica Biosystems employee, you will be consistently challenged to deliver your best.
If you are seeking a new challenge where your performance and contribution is valued, and the role aligns with your next career move, we would love to hear from you.
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