Manager, Regulatory Affairs Position Description
- The Regulatory Affairs Manager is responsible for preparing, filing and gaining approval of Submissions to regulatory authorities in the US, European Union, Asia and the Middle East.
- The RA manager maintains marketability of existing products and ensures department objectives are met.
- This position requires a working knowledge of regulations and guidances.
- This individual assists in refining RA processes and provides regulatory expertise and compliance for all global product development, clinical development and Marketing functions.
- This individual must be enthusiastic, positive, dependable, flexible and able to build relationships working as part of a team and working independently.
- Manage preparation and filing of International regulatory submissions for the European Union, Asia and the Middle East, utilizing clinical study data as well as verification and validation test data.
- Manage preparation and filing of 510(K), IDE and FDA submissions.
- Manage directed regulatory projects, developing and executing regulatory plans including product changes.
- Work proactively with project teams and RA management to manage and resolve submission issues.
- Write, review and edit regulatory submissions as appropriate and format, publish and submit documentation in accordance with requirements and regulatory guidance.
- Create regulatory strategies for submissions, protocol development and Clinical studies to ensure most efficient approval times.
- Work with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed.
- Manage and maintain Technical file for CE marking
- Manage and maintain STED documents for OUS Submissions
- Manage the archival and tracking of regulatory documentation, including: correspondence, labeling, data packages, forms, submissions and related materials submitted to regulatory agencies.
- Interact proactively with regulatory authorities and build good, effective working relationships to meet company goals.
- Assist in approval of product labeling, technical publications and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are adequate, and all product claims are properly supported. Recommend new or modified product use and warning labeling changes in response to new information.
- Assist in medical device reporting of customer complaints.
- Assist in the development and documentation of regulatory processes and procedures and a plan for their monitoring.
- Assist in advising on issues of product/process quality and risk assessment and in review and approval of proposed product design and specification change plans to assess impact on registrations.
- Keep current with regulations and guidance documents for US and OUS countries where products are marketed.
- Assist with other regulatory matters as needed.
- Bachelors of Science or BA degree in life sciences or equivalent.
- Minimum 5 years' experience in Regulatory Affairs in the medical device industry or pharma experience with psychiatry or neurology product is ideal
- Evidence of strong collaborative and team leadership experience
- Cross-functional experiences in working with teams and/or leading and supporting product development and marketing teams
- Sound basis of regulatory knowledge with preferred experience and proven ability to prepare device applications (i.e. IDEs, 510(s), PMA(s), EU, Japan and other regions).
- Knowledge of GMP, GLP, GCP and Quality Systems requirements.
- Strong project management skills and ability to manage complex projects and timelines within a team environment.
- Ability to independently identify compliance risks and escalate when necessary.
- Excellent organizational skills, self-directed and attentive to detail with ability to multitask.
- Strong oral and written communication skills.
- Excellent computer aptitude and document formatting skills.
- Strong problem-solving skills and ability to deal with changing priorities.
- Knowledge of medical device requirements including QSR, CAMDCAS, ISO 9001/13485
- Experience in a start-up or small company environment is preferred.
- Close involvement in at least one complete medical device product development cycle from product development through marketed product.
- Demonstrated ability to stay abreast of changes in FDA regulations and international regulatory standards.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.