7 Regulatory Affairs Specialist Jobs in Wilmington, DE
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Katalyst Healthcares & Life Sciences is Hiring a Regulatory Affairs Specialist Near Wilmington, DE
- Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards.
- Leads Regulatory on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.
- Actively engages with cross-functional teams (as required) to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion.
- Coordinates (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions.
- Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manages expirations / renewals and planning for new applications.
- Manages and oversees relationships and interactions with Health Authorities (HAs) to ensure the company's knowledge of requirements and expectations is current and robust; shares this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks.
- Participates in any relevant regulatory improvement projects.
- Bachelor's degree or higher in Life Sciences, Engineering, or related disciplines.
- Minimum of 5 years plus experience in Regulatory Affairs.
- Experience working with Class I, II and III medical devices.
- Deep understanding of relevant laws, regulations, and guidelines governing the development, approval, and marketing of medical devices.
- Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA.
- Strong working knowledge of EU (MDD / MDR) medical device regulations and submissions.
- Experience and proven ability in preparing US regulatory submissions e.g., IDE, 510(k), PMA, and technical documentation.
- Knowledge of Quality Systems requirements such as QSR, ISO 13485, GxP.
- Strong leadership and project management skills and ability to manage complex projects and timelines within a team environment.
- Ability to identify compliance risks and escalate when necessary.
- Demonstrated ability to stay abreast of changing regulations and standards.
- Excellent computer aptitude and document formatting and publishing skills.
- Strong problem-solving skills and ability to deal with changing priorities.
Job Summary
Full Time
$104k-133k (estimate)
05/12/2024
05/14/2024
katalysthls.com
South Plainfield, NJ
<25
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