Sr Regulatory Affairs Specialist
Sr Regulatory Affairs Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams as well as clients regulatory team to navigate the regulatory landscape and ensure a smooth and successful product launch.
Roles & Responsibilities :
Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products.
Provide regulatory guidance and support to our engineering and testing teams ensuring that the system design development and testing activities comply with relevant regulations and standards (IEC 62304 FDA guidelines ISO 13485 etc..
Assist in the preparation and submission of regulatory documentation including 510(k) premarket notifications or PMA applications (as applicable) ensuring completeness accuracy and adherence to regulatory guidelines.
Monitor and track regulatory changes and updates keeping the team informed of any relevant developments and advising on necessary adjustments to the project plan or system design.
Conduct regulatory research and analysis providing insights and recommendations on regulatory strategies and compliance requirements.
Maintain uptodate knowledge of relevant regulations standards and guidance documents related to medical devices.
Support internal audits and regulatory inspections ensuring that all documentation and processes are compliant.
Collaborate with crossfunctional teams (engineering quality marketing) to ensure that regulatory requirements are considered throughout the product lifecycle.
Qualifications :
Educational qualification:
Bachelors degree in a scientific or engineering discipline.
Experience :
Minimum of 5 years of experience in regulatory affairs within the medical device industry.
Mandatory/requires Skills :
Minimum of 5 years of experience in regulatory affairs within the medical device industry.
Strong understanding of FDA regulations HIPAA regulations and international standards (IEC 62304 ISO 13485.
Experience with 510(k) submissions or PMA applications is a plus.
Excellent communication interpersonal and organizational skills.
Ability to work independently and as part of a team.
Strong analytical and problemsolving skills.
Preferred Skills :
Experience with medical products such as implants pacemakers ventilators etc.
Familiarity with Polarion ALM.
RAC (Regulatory Affairs Certification) or other relevant certifications.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
