Director of Regulatory Affairs
Job Description:
Innovia Medical combines the experience and expertise of Summit Medical, Network Medical, DTR and Eagle Labs to help our medical professional partners elevate the delivery of care to improve patient outcomes. We develop products not just for our customers, but with our customers. Our collaborative approach cultivates innovative medical solutions for the global healthcare industry. Through excellence in design, supply chain management, manufacturing and customer service we put Quality at the forefront in all aspects of our business.
Job Summary
Director of Regulatory Affairs has overall global Regulatory oversight and responsibilities of the US companies of the Innovia Medical Organization. As and when required the Director of Regulatory Affairs will provide Regulatory guidance and support to the other non-US Innovia Medical Organizations.
Essential Duties and Responsibilities
- For US companies of the Innovia Medical Organization, acting as the Person Responsible for Regulatory Compliance and responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10) of the Medical Devices Regulation.
(d) the reporting obligations referred to in Articles 87 to 91 of the Medical Devices Regulation are fulfilled.
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the Medical Devices Regulation is issued.
- To lead, mentor, guide and develop individual members, of the US Regulatory Affairs department.
- Responsible for ensuring that all Medical Devices comply with all applicable regulations in relation to the countries in which they are sold.
- Successful approval and maintenance of all product registrations with no unplanned loss of registration validity.
- Update and maintain all Technical Files / documentation to meet all current regulations.
- Conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
- Ensuring that Technical documentation and the EU declaration of conformity are current and accurate.
- Obtaining product regulatory approvals as needed (FDA, EU, Canada, etc.) (510k, Technical File, CE Mark, Product License, etc.)
- Establish Regulatory strategies to support the organization’s goals.
- Supports the organizations through the change activities.
- Following all regulations, standards, procedures, and work instructions defined in the Quality System Manual
- Leading regulatory aspects of FDA inspections, Notified Body audits and other audits performed.
- Leading all Technical file audits undertaken by the Notified Body and File reviews performed by the EC Representative.
- Maintaining FDA device listing and performing annual facility registrations.
- Maintaining UK MHRA product listings.
- Performing annual Canadian product licenses renewals
- Performing change notifications (significant) to regulatory agencies (FDA, Notified Body, Authorized Representative, Canada, etc.) and tor the EU Representative
- Act as the named US Representative with the FDA for the Foreign Innovia Medical companies.
- Maintaining Certificate of Foreign Government (CFG) and requesting CFG, Certificates of Free Sale (CFS), and Free Sales Certificates as required for overseas registrations.
- Acting as the on-site expert on all regulatory matters, providing advice, guidance to QA, Manufacturing, and other managers in the senior team as appropriate.
- Facilitates continual improvement and compliance to regulatory processes.
- On time reporting of metrics per business requirements.
- Other duties as assigned.
Experience & Education Requirements
- Bachelor’s degree or equivalent education in a scientific, engineering, life sciences, or technical discipline.
- A minimum of 10 years’ experience in Regulatory Affairs in a medical devices environment.
- Strong working knowledge of US FDA requirements and guidance’s, Australian Therapeutic Goods Act and Health Canada Food and Drugs Act.
- Experience of 510k's.
- Good working knowledge of EU regulations MDD and MDR.
- Experience of MDSAP for US/Health Canada, Australia preferred but not essential.
- Strong working knowledge of common Medical Devices standards including but not limited to FDA CFR 820 ISO13485, 14971, 15223-1, 10993 series, ISO 20417.
- Working knowledge of Medical Device quality systems
- Understating of ISO 13485, FDA QSR 820, ISO 14971
Preferred Skills & Abilities
- Strong communication and interpersonal skills, including the ability to give feedback.
- The ability to make clear decisions in a creative, pragmatic but compliant manner.
- Strong investigation, critical evaluation and problem-solving skills.
- Ability to lead, manage and inspire team members and stakeholders.
- Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written, are needed. Some flexibility on working hours preferred as the role will involve interaction with US manufacturing sites.
- Ability to handle multiple tasks with high attention to detail.
- Flexibility and ability to adapt to changing situations.
- Ability to assimilate information, summarize and present in the format required.
- Must take initiative and have a hands-on approach.
- Good organizational ability and time management.
- Good IT literacy is required with Microsoft Suite of products.
We offer a full complement of benefits including health, dental, vision, life insurance, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.
This position is on-site at our corporate headquarters in Eagan, MN (near 494/Dodd)
This position is not eligible for a relocation package
Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status). EOE/Disabled/Veteran
