|Title:||Director of Regulatory Affairs|
|Job Location:||Salt Lake City, Utah - United States|
|Salary:||$130,000.00 - $150,000.00 - US Dollars - Yearly|
|Other Compensation:||15% bonus|
|Employer Will Recruit From:||
US Medical Device firms
Work for a leader in this 100 year old, international class II medical device company. They offer stability and growth and are a leader in their market.
Director of Regulatory Affairs – North America Class II Medical Device
Reports to: Head of Global Regulatory Affairs
Reports to VP Operations Americas
Position Located in: Salt Lake City, UT - Has 4 direct reports Will manage 4 people : Complaint Officer, Regulatory Affairs Specialist, Quality Tech, Quality Engineer.
· Contribute to Company’s Regulatory Affairs (RA) strategy; ensuring compliance within the United States and Canada.
· Manage regulatory and compliance strategies for products from North America companies ensuring marketability of these devices in all defined target markets.
· Partner with Quality Management to support the major work packages of complaint management, risk management, pre-market and post-market activities.
· Act as liaison between the Company and Health Regulatory Authorities. Control and oversee all North American compliance issues and cooperate with the non- North American companies on all compliance issues.
· Provide strong leadership over entire Regulatory and Quality functions and among peers, ensuring departmental activities are aligned with overall Company goals and strategies.
· Proactively collaborate with other regional functions (Operations, R&D, Sales, etc.)
· They are launching a new Class II medical device sometime this year and they think it will trigger an FDA Audit. They need someone who can represent them well and proactively prepare them in advance for this and/or any future audits they might have.
· Bachelor’s degree in technical engineering or scientific area. Master’s degree / MBA preferred.
· 10+ years significant Regulatory Affairs and Quality experience to include management roles in the medical device industry (experience with mechatronical and/or neurotherapeutic devices is preferred). Experience with at least class II products, experience with higher class devices is a plus.
· Experience in development and maintenance of Quality Systems. Has lead or participated in GMP (QSR, 13485) audits.
· Experience in the development of effective regulatory compliance strategies, assessment of corporate risks related to regulatory and development activities; building a compliance function; and the management, mentoring, and development of employees (not necessarily reporting directly to the incumbent).
· Quality orientation and high attention to detail.
· Demonstrated ability to work in a highly matrixed organization, to lead through influence and evolve compliance throughout a company.
· Ability to travel both domestic and international.
· Excellent working knowledge of regulatory requirements for FDA registration and sound broad knowledge of regulatory guidelines for other major health authorities.
· Demonstrated ability to drive innovative strategies with various agencies.
· Proven ability to perform in high–visibility, high-growth environments.
· Credible; has integrity; is open minded and ethical.
· Excellent verbal, written and interpersonal communication skills.
University - Bachelor's Degree/3-4 Year Degree