Manager, Global Regulatory Affairs
Who is Drive DeVilbiss…
Formed in 2000, Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail and e-commerce channels in more than 80 countries around the world.
“Our Mission is to enhance the quality of life of the people we touch”
The Manager, Global Regulatory Affairs will have multi-site responsibility for the Class II Medical Device production facilities located in Somerset, PA (DeVilbiss) & Ft. Myers, FL (Inovo). The Manger, Global Regulatory Affairs will ensure appropriate facilitation of the Regulatory pathway for Inovo and DeVilbiss products throughout the world. This shall include the management, coordination, and administration of regulatory submissions and adverse event reporting. Additionally, this role shall manage, coordinate and administer various aspects of the customer complaint system including corrective actions, regular distribution of complaint reports, and monitoring of analytical data trends for continuous product quality improvement. The role is also responsible for the compilation and maintenance of technical files for applicable products with a strong focus on European markets. Travel will be between 10-25% depending on where the candidate is located.
The Manager, Global Regulatory Affairs provides multi-site management of Regulatory Affairs Project Management, including technical files, DHR/DMR/DHF, and product complaints for manufacturing sites in North America and suppliers globally, in accordance with regulatory and internal requirements for medical device regulations and standards. This includes, but is not limited to, the following:
- ISO 13485:2016 Requirements for regulatory purposes
- TG(MD)R Sch3: The Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations
- RDC ANVISA 16/2013: Brazilian Good Manufacturing Practices
- MHLW MO 169: Japanese QMS Ordinance
- 21 CFR Part 820: The Quality System Regulation
- MDSAP Companion Document 2017-01-06 MDSAP AU G0002.1.004
- (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (EU MDR, in transition)
Accordingly, this position is responsible to:
- Supervise the maintenance of product-related files, including technical files, DMRs, DHRs,
and DHFs, by managing cross-functional inputs to ensure well-organized and dynamic files ready for submission.
- Utilize project management principles to advance multiple Regulatory Affairs projects at different sites simultaneously.
- Apply principles of risk-based/risk-benefit analysis and decision making to Regulatory Affairs submissions, including but not limited to registrations and adverse event reporting.
- Verify the regulatory status, on a dynamic basis, of Class II and IIb devices in multiple global jurisdictions, including the organization’s ability to ship and distribute product.
- Ensure collaborative relationships with global regulatory bodies as well as between the regulatory cohort in other Drive DeVilbiss Healthcare organizations.
- Conduct Medical Device Reporting.
- Coordinate and administer field actions including product recalls, remedial actions, corrections and follow-up with regular monitoring and reporting to FDA, Health Canada and other Global Regulatory Bodies through affiliates.
- Assist with Establishment Registrations and Device Listing updates, with the FDA and other regulatory authorities.
- Coordinate with engineering by performing initial regulatory review for the New Product Development Process, and to perform regulatory review for product design changes and provide documented 510(k) rationalization/updates to CE Technical File.
- Manage and maintain the international product regulatory registration process.
- Maintain all applicable Federal and State License Certificates from various US States.
- Assist in the creation and review of Labeling and marketing material.
- Fulfill requests for Certificate to Foreign Government, Apostille, Notary and Consulate Stamp.
- Assist with CAPA reviews and meeting action items.
- Review and sign off on Deviation and Rework orders.
- Lead complaints process and repair records for adverse event monitoring and reporting.
- Assist and serve as a resource during GMP/ISO Audits and other activities related to operation of the Somerset facility under FDA/Health Canada Guidelines, EU MDD and ISO13485 requirements.
- Assist in the performance of internal audits.
- Provide training to direct reports to ensure compliance to regulatory requirements.
- Regulatory Affairs expertise in North America, EU, and Latin America Medical Device Industry
- Expertise in applicable ISO standards, 13485, 14971, FDA 21 CFR Part 820
- Solid critical thinking skills
- Utilization of compliance gap analyses to effect positive organizational change
- Attention to detail
- Versed in international business customs and communication styles
- Excellent skills in presentation, written and verbal communication
- RAC preferred
Education and Experience:
- Bachelor’s degree in Engineering or Life Sciences, or equivalent experience.
- At least 7 years relevant experience of progressing responsibility in Regulatory Affairs in the Class II or higher Medical Device Industry.
- At least 5 years of supervisory experience.
- Experience in European and Latin American regulatory affairs.
- Experience developing and implementing the regulatory pathways for 510(k) and CE Marked products.
- Root Cause Analysis experience and expertise required.
- Proficiency in EQMS preferred.
Why Apply to Drive DeVilbiss…
Competitive Benefits, Paid Time Off, 401(k) Savings Plan
EEO Statement: Drive DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Drive DeVilbiss complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
Learn more here
Job posted: 2020-09-22