WHO WE ARE:

Theradaptive is revolutionizing the field of targeted therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in regenerative medicine, working at the interface of Biology and tissue repair.

Our lead therapeutics are in the following indications:

• Spinal Fusion
• Trauma Repair
• Dental and Facial Bone Repair

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects. At Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process firsthand, bridging both Biologics and Devices. Transform your career and join the Theradaptive team today!

POSITION SUMMARY:

We seek a talented Director of Regulatory Affairs to be part of our growing team. This person will have primary responsibility for overseeing regulatory matters and developing strategies to ensure compliance with regulations related to medical devices. They will provide regulatory guidance to project teams regarding design controls, product development, evaluation, and marketing.

The ideal candidate will have experience with PMA preparation, IND/NDA preparation, and IND module preparation and submission requirements. They will also have experience with combination products and associated rules for RFDs, having processed at least one combination product. The Director of Regulatory Affairs will also have expertise in device and drug cGMP, and regulatory work in more than one country.

RESPONSIBILITIES:

• Reports to the Senior Vice President for Regulatory and Clinical Operations
• Serve as Regulatory Lead on assigned project teams (early phase, late stage and marketed products).
• Develop innovative and sustainable medical device regulatory strategies covering combination products.
• Prepare regulatory filings including RFDs, 501Ks, pre-submissions, IDEs, and PMAs
• Provide regulatory guidance and advice to development teams.
• Review and approve design control deliverables.
• Lead and/or support global filing activities for combination product submissions.
• Contribute to product development planning.
• Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.
• Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.
• Lead and/or support device related health authority interactions.
• Provide regulatory impact assessments for proposed product changes.
• Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
• Contribute to internal regulatory processes and procedures for combination products.
• Engage with the relevant regulatory bodies, including conducting calls, submitting regulatory filings and correspondence, and coordinating meetings at regulatory agencies.

QUALIFICATIONS:

Education, Skills, and Training:

• Bachelor’s or master’s degree in life sciences or statistics (working experience more important than formal education or an advanced degree)
• Solid understanding of both device and drug regulations well as combinations thereof
• GCP training required
• API and finished pharmaceutical training required
• GLP training preferred
• Solid understating of Quality control and statistical quality control required

Experience (preferred):

• Direct experience in clinical trials including endpoint designs
• Experienced auditor (mfg., and Clinical as well as company audit management)
• 2-5 years of experience with a PMA and its preparation required
• 2-5 years of experience with IND/NDA preparation required
• Experience with Combination products and associated rules for RFD’s having at least processed one combination product
• Working knowledge and experience in IND module prep and steps required
• 3-5 years of experience and high expertise in device and drug cGMP required
• Experience working with notified bodies required
• Experience in more than one country (regulatory work with Competent Authorities) required
• Experience in more than one field of clinical medicine
• 20+ years of experience in above fields preferred
• Working knowledge of biostatistics preferred
• Experience in trial execution programs (EDC, oracle clinical, Viedoc, Sure clinical, TMF systems or similar) preferred
• Experience in implementation of cGMP systems preferred

PHYSICAL DEMANDS:

Office related tasks, able to travel abroad to partner sites

POSITION LOCATION:

This position may work remotely from any location. This position requires travel to the Theradaptive headquarters in Frederick, MD once per calendar quarter for on-site meetings.

https://www.theradaptive.com

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.