Director, Regulatory Affairs

Job Title: Director, Regulatory Affairs

Job Number: 32467

Location: 5350 Partners Court Frederick, MD 21703

Job Description

We seek a talented Director of Regulatory Affairs to be part of our growing team. This person will haveprimary responsibility for overseeing regulatory matters and developing strategies to ensure compliance with regulations related to medical devices. They will provide regulatory guidance toproject 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.

Required Skills

 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