Senior Manager, Regulatory Affairs (Device)
Senior Manager, Regulatory Affairs (Device)
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$ 160 - 180
1 Vacancy
Job Description
About SpyGlass Pharma:
At SpyGlass Pharma we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.
We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra We create for patients doesnt just live on our walls but drives our decision making as we build the company creating the products processes and culture that make it happen.
This team has delivered a solid foundation of development and clinical data enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.
Summary:
We are seeking an experienced and strategic Senior Manager of Regulatory Affairs to join our team. In this role you will partner with the SVP Quality & Regulatory Affairs in developing and implementing regulatory strategies with a strong emphasis on medical devices and drug-device combination products. This role supports the advancement of SpyGlass Pharmas innovative ophthalmic technologies through clinical development and into commercial readiness. The successful candidate will lead and resolve complex regulatory issues related to design controls development and manufacturing while collaborating with interdisciplinary teams to ensure regulatory compliance and submission readiness.
Essential Duties & Responsibilities:
- Support the SVP Quality & Regulatory Affairs in developing and executing global regulatory strategies for Class III ophthalmic devices and combination products.
- Provide regulatory guidance on device-specific requirements including Design Controls usability risk management and technical documentation in accordance with 21 CFR 820 ISO 13485.
- Review and approval all device specific development and manufacturing documentation.
- Contribute to the preparation and review of regulatory documents for device content to support product development regulatory submissions and Agency meetings.
- Address and resolve complex regulatory issues related to device development design verification/validation labeling biocompatibility and manufacturing scale-up.
- Participate in regulatory agency interactions including FDA meetings.
- Collaborate cross-functionally with R&D Clinical Quality Assurance and Operations to support development submission and lifecycle management of regulatory filings.
- Monitor and interpret evolving global regulations and provide proactive guidance on their impact to product development programs.
- Ensure regulatory documentation is current accurate and maintained in accordance with internal procedures and regulatory expectations.
- Develop and implement robust regulatory pathways to enable successful US and international clinical trial application submission and approvals.
Qualifications Required For Position:
- Bachelors degree in a relevant scientific or engineering discipline; advanced degree (e.g. Masters) preferred.
- 810 years of experience in regulatory affairs within the medical device or combination product industry including strong knowledge of device-specific regulations. IOL experience is a plus.
- Direct experience in IDE PMA and 510(k) life cycle management submissions and FDA meetings.
- Deep knowledge of applicable FDA regulations (21 CFR) ISO 13485 EU MDR and ICH guidelines.
- Demonstrated success in developing regulatory strategies negotiation with CDRH on complex regulatory strategies and managing IDE and PMA submissions for Class II/III devices in the US.
- Experience with Design Controls risk management and lifecycle management of device or combination products.
- Proven ability to manage multiple priorities communicate regulatory requirements effectively and collaborate cross-functionally.
- Excellent written and verbal communication skills with strong attention to detail.
Why SpyGlass Pharma
- We are offering a range of $160000 - $180000 based on experience and qualifications along with an Annual Bonus opportunity.
- Share in our success with stock options giving you a stake in the companys future.
- Comprehensive health dental and vision insurance plans to keep you and your family healthy and happy with a variety of plan and coverage options.
- Generous paid time off including holidays vacation days and personal leave.
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status.
SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Required Experience:
Senior Manager
Employment Type
Full-Time
