Regulatory Affairs Manager – US
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
As a Regulatory Affairs Manager, US you will be responsible for providing relevant regulatory inputs throughout the product life-cycle to ensure that relevant global regulations, guidelines, policies, guidance documents and standards are correctly identified and applied in ADC projects and activities.
You will represent ADC in interactions with regulatory authorities, including building relationships, liaising & negotiating when needed.
You will keep the company aware of emerging issues in the regulatory environment and the impact on business operations. You will develop strategies to mitigate against regulatory risk.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
- Assess, provide direction and approve product labelling and marketing promotional material (IFU, leaflets, brochures, webpages etc.) to ensure full compliance with the applicable parts of US legislation, regulations and FDA guidance’s
- Responsible for all activities related to device and owner/operator listing including payment of fees for ADC products and establishments. Maintains overview of data needed for FURLS listing.
- Critically evaluate and make a decision if design, manufacturing, and labelling changes and documents support on whether to submit or not a new premarket notification via Letter to File or as appropriate. Critical decisions to maintain compliance for the company.
- Provides ADC Product RA project teams with feedback on the impact of the change on market access, as well as provide requirements and timelines for change notifications and approvals. Provide inputs to mitigate against regulatory risks. Defend all changes to regulator.
- Responsible to submit, on behalf of US Product RA team, regulatory filings for significant changes to secure FDA marketing clearance/approval, as needed.
- Ensure OUS (outside US) regulatory submission preparations, document filings and communication with all government agencies responsible for regulating our products, to include compiling and prepare responses to address regulatory authorities’ questions concerning the submitted materials as needed
- Identify the need for and manage consultants when necessary to achieve on-time registrations
- Provide regulatory support of US commercial initiatives, tenders etc.
- Responsible for all activities to support products subject to Import for Export to ensure continuous supply. Activities include, but not limited to maintain database, respond to FDA border actions, create Import for Export documentation, ensure FURLS listing of the product and relevant contract manufacturers
- Report submission progress to ADC project teams and senior management as needed
- Communicate and work closely with all relevant internal and external stakeholders to deliver regulatory outcomes that enable business plans.
- Develop, maintain and review relevant regulatory SOPs, Work Instructions and templates.
- Support internal and external audits and inspections including preparation and closure of audit outcomes for all Regulatory work
- Acts as the named US Agent or US Official Correspondent as when needed
- Monitor regulatory changes in regulations and Guidances. Monitor the US regulatory environment for changes in the market place and regulator positions. Influence Regulators and Industry Groups on behalf of Ascensia.
- Analyze impact of new and changing regulations and inform the business in a timely manner on emerging regulatory issues. Develop strategies to mitigate regulatory risks.
- Support or drive improvement projects in regulatory related processes and procedures
- Train, assist and provide guidance to other RA team members and other departments and stakeholders in US regulatory requirements.
- Participate in external standards bodies and/or trade associations as the Ascensia Diabetes representative to shape requirements and policy affecting Ascensia devices
- Maintain competitive intelligence on Ascensia products, including product licenses and post market data – periodically summarize and communicate such intelligence to relevant stakeholders
- Bachelor’s or Master’s degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related field of study; PhD is a plus
- 5-10 years of experience in medical device industry
- Regulatory experience with in vitro diagnostics and mobile medical apps is a plus
- 5+ years of direct experience in regulatory affairs for Class II or above
- Extensive knowledge of medical device development and design control process
- Superb written and verbal communication skills, excellent proofreading and editing skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Excellent organizational, multitasking, and prioritization skills
- Strong working knowledge of regulations in US, EU and other Global Regulators is a plus, as is active participation in policy and requirements development with external bodies
- Ability to work collaboratively with cross-functional teams and utilize critical thinking to analyze problems which may require multiple factors and approaches
Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES:
Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer including Disability/Protected Veterans.
If you are interested in applying for employment with Ascensia and need special assistance or an accommodation to use our website, please contact us at ApplicantAccommodations@ascensia.com
Job posted: 2021-03-03