Manager of Regulatory And Quality
Regulatory Affairs Manager
Waltham, MA, USA
Seeking a senior / principal level regulatory affairs professional who is ready to advance to a manager role and lead a team at a growing organization.
Our client is the largest privately owned IVD company in the U.S. with over 1,200 employees globally. With eight percent compounded annual growth over nearly a decade shows more than double the IVD market growth, making our client one the fastest growing IVD companies in the world.
As the Regulatory Affairs Manager, you will ensure company compliance to FDA QSR, MDSAP, IVDD/IVDR, ISO 13485, ISO14971, and ISO 15197 as well as any additional regulatory requirements. You and your team will be responsible for worldwide new product submissions and registrations.
Essential Responsibilities and Accountabilities:
- Manage and support a variety of regulatory requirements, including, but not limited to, the following areas.
- European regulatory requirements, e.g. design dossier and technical file compliance, vigilance reporting, ROHS, application and use of European harmonized standards.
- US regulatory requirements, e.g. premarket notification (510K) compliance, MDR reporting, quality system compliance, Unique Device Identifier (UDI) requirements, application and use of FDA guidance documents.
- Rest of World (ROW) regulatory requirements, e.g. submissions and registrations, adverse event reporting, interactions with Regulatory agencies, Distributors and Nova subsidiaries.
- Development and communication of regulatory strategies for worldwide markets.
- Interface and negotiate with regulatory agencies for new product approval and compliance related issues.
- Facility registrations and product listings, ISO and EC certificate maintenance, foreign registration maintenance.
- Support Product Development teams for new product introductions.
- Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the regulatory department.
- Provide external audit support during regulatory body inspections such as FDA, TUV, Partners and Customers.
- Support conducting internal audits of Nova's Quality System.
- Lead and manage a team of regulatory professionals, including hiring, mentoring, coaching, and conducting performance reviews.
- BS Degree in the Sciences, Engineering, Quality Management, or related field. MS Degree preferred. RAPS certification is a plus.
- 5-7 years of experience in regulatory affairs roles with a medical device company. IVD experience is preferred.
- Extensive knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, IVDD 98/79/EC, MDD 93/42/EEC, and MDSAP requirements.
- Collaborative spirit and a proven leader focused on driving continual improvement.
- Excellent supervisory, managerial, mentoring and leadership skills. Candidates with experience mentoring others who are interested in a step up into a managerial role are encouraged to apply.
- Ability to lead multiple projects through inception through to completion.
Highlights of benefits offered include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, and an innovative scholarship program for children of employees. Support with relocation expenses is available for the right candidate.
Applying for the job
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- Apply direct from the website (www.tecgroup.net) by clicking "apply now"
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About TEC Group International
We are TEC Group. We are international recruitment specialists. We are the link between highly-specialised industries and the professionals that make them work. Expert consultants, a global network of offices and the latest technology allow us to join the dots in the talent process.
TEC Group International supports the Scientific, Engineering and Energy sectors. We have completed assignments in over 60 countries and support projects all over the world through our subsidiaries and partners.