Regulatory Affairs Assoc - EU, MDR Submissions
Riverpoint Medical, Portland, OR, United States
Riverpoint Medical in Portland Oregon is looking to hire a
Regulatory Affairs Associate (EU MDR Submissions) . At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.
Duties and Responsibilities
Manage and oversee the preparation, compilation, and submission of regulatory filings for EU MDR.
Ensure that all submissions comply with applicable local and international regulations, standards, and guidelines.
Work closely with contractors, R&D, quality assurance, clinical, and manufacturing teams to gather the necessary documentation for regulatory submissions.
Collaborate with customers to create and maintain technical documentation for regulatory submissions.
Develop regulatory submission strategies based on product characteristics, target markets, and the latest regulatory requirements.
Review and ensure accuracy and completeness of technical documentation, labeling, risk assessments, and clinical data required for regulatory submissions.
Serve as the primary point of contact for the notified body throughout the submission and approval process.
Respond to regulatory authority requests for additional information and facilitate meetings or audits as needed.
Provide input into regulatory strategies for new product development and market expansion.
Develop and maintain submission timelines and ensure that all deadlines are met. Develop tools and tracking systems to meet deadlines.
Track the status of submissions, ensuring timely approvals and handling any delays or issues that arise.
Make quality regulatory decisions, balancing risks, and benefits.
Qualifications
Minimum 2 years’ knowledge and experience in managing EU Regulatory Affairs submissions.
In-depth knowledge and expertise in EU MDR (Medical Device Regulation) requirements and compliance are essential.
Ability to create technical documentation for customer regulatory submissions.
The ability to interpret regulations, guidance and correctly apply them as appropriate in product development.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
Ability to review detailed scientific information and assess whether technical justifications are presented clearly, and conclusions are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Customer Centric attitude, and experience with customer service is preferred
Benefits We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
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Regulatory Affairs Associate (EU MDR Submissions) . At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies.
Duties and Responsibilities
Manage and oversee the preparation, compilation, and submission of regulatory filings for EU MDR.
Ensure that all submissions comply with applicable local and international regulations, standards, and guidelines.
Work closely with contractors, R&D, quality assurance, clinical, and manufacturing teams to gather the necessary documentation for regulatory submissions.
Collaborate with customers to create and maintain technical documentation for regulatory submissions.
Develop regulatory submission strategies based on product characteristics, target markets, and the latest regulatory requirements.
Review and ensure accuracy and completeness of technical documentation, labeling, risk assessments, and clinical data required for regulatory submissions.
Serve as the primary point of contact for the notified body throughout the submission and approval process.
Respond to regulatory authority requests for additional information and facilitate meetings or audits as needed.
Provide input into regulatory strategies for new product development and market expansion.
Develop and maintain submission timelines and ensure that all deadlines are met. Develop tools and tracking systems to meet deadlines.
Track the status of submissions, ensuring timely approvals and handling any delays or issues that arise.
Make quality regulatory decisions, balancing risks, and benefits.
Qualifications
Minimum 2 years’ knowledge and experience in managing EU Regulatory Affairs submissions.
In-depth knowledge and expertise in EU MDR (Medical Device Regulation) requirements and compliance are essential.
Ability to create technical documentation for customer regulatory submissions.
The ability to interpret regulations, guidance and correctly apply them as appropriate in product development.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
Ability to review detailed scientific information and assess whether technical justifications are presented clearly, and conclusions are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Customer Centric attitude, and experience with customer service is preferred
Benefits We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
#J-18808-Ljbffr