Regulatory Affairs Manager

Boston - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.
Regulatory Strategy Development: Develop and implement regulatory strategies to achieve timely product approvals.
Submission Preparation: Prepare and submit regulatory documents to relevant regulatory agencies (e.g. US EU Health Canada).
Serve as primary point of contact with regulatory body managing communications and addressing questions or concerns relative to product/project.
Regulatory Intelligence: Monitor and interpret changes in regulatory guidelines and standards and assess their impact on the company.
Lead Regulatory communications to the broader organization on pertinent regulations updates.
Compliance Monitoring: Ensure ongoing compliance with regulatory requirements including post-market surveillance.
Cross-functional Collaboration: Collaborate with R&D PPM (product and project manager) QA marketing commercial and other departments to integrate regulatory requirements into product development and commercialization.

Requirements:

Bachelors degree and/or Masters in Biology Chemistry bio-engineering or related scientific area.
5 years of medical device IVD Regulatory Affairs experience to include either 510(k) or PMA Notified Body (NB) submissions.
Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer).
Proficient in the aspects of regulatory strategy creation design control cGMP/Quality Systems and import/export requirements.
Experience in direct communication with regulatory agencies.
Regulatory review experience of promotional marketing materials press releases labeling etc.
Strong oral and written communication skills as well as the ability to provide scientific presentations!.
Ability to compile data and summarize results.
Continuous improvement minded familiar with balancing Quality and the need for efficiency.

Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. Regulatory Strategy Development: Develop and implement regulatory strategies to achieve ...

Responsibilities:

The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.
Regulatory Strategy Development: Develop and implement regulatory strategies to achieve timely product approvals.
Submission Preparation: Prepare and submit regulatory documents to relevant regulatory agencies (e.g. US EU Health Canada).
Serve as primary point of contact with regulatory body managing communications and addressing questions or concerns relative to product/project.
Regulatory Intelligence: Monitor and interpret changes in regulatory guidelines and standards and assess their impact on the company.
Lead Regulatory communications to the broader organization on pertinent regulations updates.
Compliance Monitoring: Ensure ongoing compliance with regulatory requirements including post-market surveillance.
Cross-functional Collaboration: Collaborate with R&D PPM (product and project manager) QA marketing commercial and other departments to integrate regulatory requirements into product development and commercialization.

Requirements:

Bachelors degree and/or Masters in Biology Chemistry bio-engineering or related scientific area.
5 years of medical device IVD Regulatory Affairs experience to include either 510(k) or PMA Notified Body (NB) submissions.
Preference would be a former regulatory agency reviewer or staff (e.g FDA submission reviewer).
Proficient in the aspects of regulatory strategy creation design control cGMP/Quality Systems and import/export requirements.
Experience in direct communication with regulatory agencies.
Regulatory review experience of promotional marketing materials press releases labeling etc.
Strong oral and written communication skills as well as the ability to provide scientific presentations!.
Ability to compile data and summarize results.
Continuous improvement minded familiar with balancing Quality and the need for efficiency.