Global Regulatory Affairs Manager
Global Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Develop and implement regulatory filing timelines for new and existing products in key markets such as US EU and Asia markets.
- Prepare and submit new global market device applications and amendments.
- Prepare and oversee the review of Traditional 510(k) Premarket Notifications.
- Interact with regulatory agency reviewers as well as distribution partners to facilitate product registrations and third-party license holders.
- Write and maintain EU MDR technical documentation including change notifications and lead EU related regulatory activities.
- Lead global regulatory assessments for product and manufacturing process changes via the document control process. Prepare and submit global regulatory product updates as required.
- Serve as the voice of regulatory on cross-functional teams including working with product development and manufacturing engineers to ensure regulatory requirements are incorporated throughout the product lifecycle.
- Interpret applicable standards regulations and directives to ensure global regulatory compliance.
- Review product labeling for global compliance.
- Develop regulatory processes that apply to US and international locations.
- Participate in regulatory body audits.
- Bachelors degree in science Engineering Regulatory Affairs or other technically related fields.
- 8-10 years of experience with Class II and/or III medical devices including EU MDR/MDD experience. Devices containing software and hardware systems preferred.
- Extensive experience writing/authoring US EU and other key market submissions.
- Experience with international medical device regulations standards and guidance documents including MDSAP EU MDR and ISO 13485.
- Excellent regulatory-focused writing skills communication skills interpersonal and collaboration skills.
- Attention to detail and ability to manage and prioritize multiple projects simultaneously.
- Effective time management and outstanding organizational skills.
- Demonstrated capabilities as a people manager including proven experience delegating and mentoring.
- RAC certification is a plus.
Employment Type
Full Time
