Planet Pharma ยท 1 day ago
Regulatory Specialist II
South Portland, ME
Full-time
Onsite
Mid Level
$35/hr - $38/hr
4+ years expPlanet Pharma is focused on the Infectious Disease business unit, and they are seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. The role involves providing regulatory support for diagnostic product development and ensuring compliance with regulations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR)
Provides regulatory support for diagnostic product development and commercial diagnostic products
Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally
Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments
Researches and communicates scientific and regulatory information in order to write submission documents
Compiles and publishes all material required for submissions, license renewals, and annual registrations
Maintains approvals/licenses/authorizations for existing marketing authorizations
Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations
Develops internal procedures and tools
Conducts informational or training sessions for stakeholders
Organizes and maintains hard copy and electronic department files
Demonstrates commitment to the development, implementation and effectiveness of the companies Quality Management System per ISO, FDA, and other regulatory agencies
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companies policies and practices
Qualification
Required
Bachelors Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience
4+ years experience in Regulatory Affairs role
Strong knowledge of IVDR and EU regulatory requirements is required
Good knowledge of EU and international regulations
Demonstrated written and verbal communication skills
Strong time management skills, with the ability to work on multiple projects simultaneously
Ability to work independently as well as within a team
Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
Preferred
1+ years experience in an IVD or medical device manufacturing environment
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase