Lead RA
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Key Areas of Responsibility:
Translates regulatory intelligence into actionable local regional and global regulatory strategies aligned with business goals.
Anticipates regulatory risks and emerging issues offering proactive solutionsoriented guidance throughout the product lifecycle.
Evaluates products for classification jurisdiction and marketaccess requirements identifying the most efficient regulatory pathways.
Provides technical regulatory input across quality preclinical clinical and manufacturing teams to ensure compliance.
Leads regulatory submissions endtoendplanning preparing submitting and managing interactions with global health authorities.
Reviews scientific documentation (quality preclinical clinical) for completeness accuracy and regulatory acceptability.
Collaborates effectively with cross-functional teams supporting meetings with regulatory authorities and advisory committees.
Develops and enhances regulatory SOPs strengthens compliance and trains stakeholders on evolving regulatory expectations.
Manages complex regulatory projects with autonomy strong organization and sound decisionmaking.
Demonstrates inclusive leadership embracing diverse perspectives and supporting the development of Specialists/Sr. Specialists.
Adapts to challenging assignments navigates organizational dynamics and continuously builds regulatory expertise.
Qualifications
- Bachelors degree in Engineering Science or related field; Masters in Regulatory Science preferred
- 4 years of regulatory affairs experience in healthcare medtech pharma or related regulated industries
- Regulatory Affairs Certification (RAC) is a plus
- Strong understanding of regulatory pathways compliance submissions quality systems and postmarket requirements
- Excellent communication technical writing and project management skills
- Ability to operate with autonomy judgment and crossfunctional influence
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
