Regulatory Affairs Manager
Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Responsible for providing guidance to ensure that all regulatory submissions are planned communicated and performed per regulatory and business requirements. In addition this position serves as a subject matter expert on various regulations coordinating regulatory issue resolution through the use of internal resources regulatory agencies and outside consultants as needed.
- The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams.
- Document regulatory strategies for product submissions.
- Facilitate and prepare U.S. regulatory PreSubmission documents for Next Generation Sequencing and/or PCR assays.
- Facilitate FDA presubmission meetings.
- Prepare U.S. regulatory submissions (PMA PMA supplement and 510(k) for Next Generation Sequencing and/or PCR assays.
- Support EU representatives in their creation of CE/IVD Technical Files.
- Support global regulatory registration representatives for product registration activities.
- Perform regulatory assessment of new and changed products.
- Stay on top of new or revised regulations guidelines points to consider compliance guides inspection reports journals meetings etc.
- Conduct training and/or communicate appropriate materials as needed to improve the teams knowledge of working in a regulated environment.
- Assist the Regulatory department in updating improving and crafting internal policies and procedures.
- Participate in business meetings with potential new external partners.
- . or equivalent experience in Biology Chemistry bioengineering or related science.
- At least 5 years of IVD Regulatory Affairs experience.
- Handson experience with 510(k) PMA and PMA supplement submissions.
- Deep knowledge of regulatory strategy creation design control cGMP/Quality Systems and import/export requirements.
- Experience as the RA representative on project core teams.
- Strong communication and teamwork skills.
- Ability to lead multiple projects and meet deadlines.
- Capacity to communicate regulations to technical functions within the company.
Employment Type
Full Time
