If you combine substantial experience in regulatory affairs for medical devices with strong research skills, the ability to expand your knowledge as we move into new foreign markets, and the strong communication skills to serve as an in-house consultant to the business, the role of Senior Regulatory Affairs Manager offers you some compelling opportunities. You will:

• Make your mark in a new role brought on by strong growth. And, if you're coming from a Class III medical device background, we think you'll enjoy our upbeat, lower-stress environment.
• Enjoy wide visibility as you serve as an in-house consultant working with upper management and stakeholders across the globe
• Expand your skills and experience in a diverse role that will include new market expansion. You'll become an expert on markets from North America to Europe to Asia, and learn the unique requirements of new medical device regulations from the UK's Brexit to Switzerland and other countries.
• Support strong global expansion at a manufacturer of award-winning medical devices.
• Become part of an organization with a rich history of innovation in a "Best Places to Work" environment. And, in our family-oriented culture, employees are valued and appreciated.

At Aspen Medical Products we pride ourselves on making the best products in the industry, products that change people's lives. We have won many industry awards for our medical devices, which are sold through hospitals, medical practices, chiropractors, and pain management clinics. We believe that enjoying your work and making valuable contributions to business are equally vital. To that end, Aspen has been designated one of the Best Places to Work in Orange County by the Orange County Register and the Orange County Business Journal eight years in a row.

To meet the basic qualification for this role, you will have legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship. In addition, to be a good fit for the Senior Regulatory Affairs Manager opportunity, you will have:

• Bachelor of Science degree from an accredited university in a technical field  Quick question for you - click here
• 5+ years of experience in regulatory affairs for medical devices, ideally Class I
• Hands-on knowledge of and application of ISO 13485, FDA CFR 820, MDR 2017/745 and CE marking of Class I medical device experience required  Quick question for you - click here
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful file preparation, submission, and maintenance at an appropriate level for Aspen’s products
• Proven research skills
• Solid computer skills, including Microsoft Office applications, and the ability to quickly learn proprietary systems
• Outstanding interpersonal and verbal and written communication skills; ability to work with multiple levels and titles; effectively coach and train internal stakeholders
• Ability to flex your schedule as needed to take early morning overseas calls and meet other demands

Preferred but not required:

• Professional certifications such as Regulatory Affairs Certification (RAC) or Certified Quality Engineer (CQE) are a plus  Quick question for you - click here
• UK MDR, Brazil Anvisa, China CFDA, Japan PMDA and others preferred

We are currently working remotely but expect this to become a hybrid position including remote work and 2-3 days per week in the office.

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Reporting to and working in partnership with the Vice President of Quality and Strategic Initiatives, as Senior Regulatory Affairs Manager you will be responsible for the compilation and coordination of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory files for Aspen’s products sold worldwide.  Quick question for you - click here

More specifically, you will:

• Compile all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards including CE marking of Class I Medical Devices.
• Interface with regulatory agencies as it relates to audits, submissions, and inquiries.
• Ensure all technical files, risk management plans and reports, clinical evaluations are up-to-date, risk management and post-market surveillance are in compliance with current standards.
• Stay current on new regulatory or other industry initiatives that could have a significant impact on the company’s current or in-development products.
• Provide comprehensible guidance and training to interdisciplinary project teams on regulatory requirements.
• Review and advise on marketing claims on the website, brochures, or other materials.
• Develop and establish policies and standards that convey the best practices for the company.
• Review and report overall Regulatory status to the management team.
• Other duties as assigned.

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Influence and impact
While this is a hands-on position where you will serve as a functional manager with support, but no direct reports, it is also a position offering opportunities to influence and impact the business. For example, the foundation is in place but, from a regulatory perspective, you can chart the course for Aspen in regard to processes (e.g. records and documents), help set the regulatory activities appropriate for the business, and act as a subject-matter-expert who can train and communicate with Aspen personnel. 

Autonomy and support
We'll look to you to achieve your goals independently and assume ownership of your areas of responsibility. At the same time, your manager truly values proactive communication, will partner with you in multiple areas, and provide strong support. Our goal is to set you up for success, including challenging you and helping you develop professionally.

Build a progressive career
We are proactive about supporting professional development. We offer training that helps employees develop both technical and leadership skills, and we're committed to promoting from within whenever possible. There will be opportunities for growth as the company continues to grow.

Award-winning products enhance the quality of people's lives
Backed by over 25 years of R&D, Aspen Medical Products help patients cope with chronic conditions, manage pain, and heal faster (see testimonials in the video on The Role tab). Our innovative approach and strong business model have earned us distinctions. In addition to the workplace excellence awards mentioned above, we have won:

• Several Spine Technology Awards from Orthopedics This Week.
• The American Technology Award, in the medical device category, from TechAmerica Foundation.
• Awards for delivering exceptional service as a vendor, from Hanger/SPS, a leading distributor of orthotic and prosthetic patient care and therapeutic products, services and solutions.
• And others.

Exemplary culture
You will find a close-knit culture that values mutual respect at Aspen. The numerous "Best Places to Work" awards we've won represent high levels of employee satisfaction (as reported by employees) as well as excellence in benefits, pay, work/life balance and culture.

Competitive benefits package
The health, satisfaction and security of you and your family are important to your well-being and important to us. We offer a competitive salary; medical, dental and vision benefits for you and your family; life insurance; paid vacation; and a 401(k) plan with company match.

Pictured: Just a couple of the many awards we have received.

To excel in this role, you will have excellent attention to detail and the ability to help us remain compliant with applicable industry rules and regulations. We have a unique business, and although we are in the medical device space, we are in a lower classification (less-regulated) than many other products you may have experience supporting. This will require the ability to operate with some “gray area” and remain nimble and flexible to meet the needs of our business. If you are coming from a Class II or III background, this could take some getting used to as you adjust to less stringent standards. 

You'll know you're hitting the mark as you take full ownership of more projects/responsibilities, lightening the load on the VP of Quality and Strategic Initiatives. To earn that confidence, you'll demonstrate your knowledge of regulations, ability to research new areas, and clearly communicate best practices to others throughout the organization. In addition, in order to be an outstanding Senior Regulatory Affairs Manager, you will:

• Apply yourself to knowledge gain, quickly learning and filling in any gaps
• Serve as a strong consultant, accurately answering questions, such as ensuring R&D has the regulatory information they need
• Provide information in digestible and understandable terms (i.e., this is what the standard means...)
• Raise the bar companywide on regulatory knowledge
• Dig in and research as we move into new markets, ensuring we have all the needed compliance information
• Be dedicated to post-market surveillance and maintenance