
Senior Regulatory Affairs Specialist
2 weeks ago
Job Title
">Senior Regulatory Affairs Specialist - Medical Devices
Description:
- We are seeking an experienced Senior Regulatory Affairs Specialist to join our team in the development and implementation of regulatory strategies for medical devices. The ideal candidate will have a strong background in medical device regulation, including knowledge of US and EU regulations, as well as experience with post-market surveillance and adverse event reporting.
- The successful candidate will be responsible for developing and implementing regulatory strategies for new and existing products, working closely with cross-functional teams to ensure compliance with regulatory requirements.
- This role requires excellent communication and project management skills, with the ability to work effectively in a fast-paced environment and prioritize multiple tasks and deadlines.
- We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Requirements:
- Bachelor's degree in science, math, engineering, or related discipline required; Master's degree preferred
- At least 5 years of experience in medical device regulation, including post-market surveillance and adverse event reporting
- Strong knowledge of US and EU regulations, including 21 CFR 803/806/820 and ISO 13485
- Excellent communication and project management skills
- Able to work effectively in a fast-paced environment and prioritize multiple tasks and deadlines
Preferred Qualifications:
- Regulatory Affairs Certifications (RAC)
- Experience with administration and safety systems
- International regulatory competency
Travel Requirements: Up to 13 business days per year
Benefits:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Flexible work environment
Additional Requirements:
- Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
- Ability to comprehend principles of math, science, engineering, and medical device use.
- Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to organize complex information and combine pieces of information to form general rules or conclusions.
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
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