Medical Device, Quality/Risk Management, Regulatory Compliance
4 Year Degree
The Sr. Manager, Regulatory Affairs leads, reviews, makes recommendations, and coordinates programs to ensure effective regulatory strategies in adherence with relevant laws (U.S. and international laws), regulations and standards; includes 510(k)’s, state licenses, and international regulatory submissions. The Regulatory Affairs Manager promotes awareness of regulatory requirements, implements, and communicates regulatory policies to all personnel at all levels; interacts and maintains a dialogue with all relevant functions in connection with regulatory submissions; develops and maintains solid working relationships with other organizational functions (e.g. Quality, R&D, marketing).
ESSENTIAL JOB DUTIES:
Develops Global RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
Maintains a thorough working knowledge of US, Canada, EU and International laws, regulations, standards, guidance and guidelines.
Responsible for domestic and international product registrations. This includes, but is not limited to Pre-Market Notifications, 510ks, CE technical files and international dossiers (Canada, China, Brazil, Australia, Japan, Korea, etc…).
Oversees maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark.
Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Regulatory team.
Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans.
Manages and develops team of Regulatory professionals. Provides appropriate mentoring, appraisals, and discipline of direct reports.
Foster and maintain strong relationships with senior RAQA Regulatory leaders across DHR and leverage best practices and opportunities to drive cross business collaborations and initiatives.
Participates in audits and inspections of the company and its quality systems.
Participates in the Corrective Action process as a team member and potential CAPA owner.
Participates as a cross-functional team member helping to facilitate actions and communications involving field corrective actions
Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
Direct communication with regulatory authorities regarding company’s regulatory filings.
Remain current on developments in field(s) of expertise, regulatory requirements and industry trends.
Create and update departmental standard operating procedures (SOPs).
Provide regular and timely performance feedback to direct report associates to actively develop and improve their skill sets.
Timely utilization of all people management systems such as Workday and eTime.
REQUIRED EDUCATION AND/OR EXPERIENCE:
Bachelors Degree in a scientific or engineering field plus.
Minimum of (5) five years of progressive experience working with regulatory requirements and agencies; specifically FDA, the Medical Device Directive and ISO 13485 required.
Minimum three (3) years of supervisory experience effectively managing RA/QA associates required.
OTHER SKILLS and ABILITIES:
Experience with good manufacturing practices (GMP).
Experience with the 510(k) clearance process.
Working knowledge of 21 CFR Parts 803, 806, 820, 860, Canada Medical Device Regulations and EU Medical Directive requirements.
Experience with pre-market regulatory activities (new product development) as well as post market activities (recalls, complaint handling, adverse event reporting) is strongly preferred.
Regulatory Affairs Professionals Society (RAPS) certification preferred.
Ability to and demonstrated experience with multi-tasking.
Ability to plan and accomplish goals through extensive experience and judgment.
Extensive experience with MS Word and EXCEL.
Ability to handle a demanding and varied workload, be very organized, and assertive.
Excellent grammar and verbal skills; excellent English written and verbal communication skills.
Technical writing experience required.
Experience working in cross-functional teams required.
LANGUAGE SKILLS: This position requires the ability to read, write and interpret, in English, such documents as government regulations, and ensure that they are effectively communicated to company personnel. The employee in this position must be capable of developing and communicating company procedures written in English. The ability to effectively present information and respond to questions from company employees and regulatory bodies is also required.
REASONING ABILITY: Must be a team player who effectively communicates and has the ability to base actions on facts and make sound decisions. Ability to apply common sense understanding to carry out detailed written and/or oral instructions. Ability to quickly assess large amounts of information and data. The ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions. Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to communicate effectively, and apply sound business judgment are important.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls, and type on a keyboard. The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear. The employee is occasionally required to climb (stairs). The employee is occasionally required to work near moving mechanical parts.
The associate must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Implant Direct offers competitive compensation and a generous benefits package. Benefits include: Medical and dental, vision insurance, 401(k) plan with employer match, group term life & AD&D, Flexible Spending Account, Employee Assistance Program, Flexible Spending Accounts, and paid vacation and holidays. Please visit our website at www.implantdirect.com for more information about our innovative company.
Implant Direct is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Internal Number: IMP000529
About Implant Direct, a Danaher Company
Implant Direct is one of the fastest growing major dental implant companies in the world today. We’re one of the many operating companies within Danaher Corporation’s dynamic portfolio of dental companies.
Implant Direct operates a state of the art manufacturing facility in Thousand Oaks, California. We manufacture and distribute a broad range of value priced surgical, prosthetic and regenerative solutions to dental professionals in the US, Canada, and around the globe. We design and develop products which make high quality implants more accessible to patients around the world. We educate dentists on how to place implants and improve their patient care.
If you are interested in working in a lean, fast moving, entrepreneurial environment where you can learn, grow and make a difference, join us at Implant Direct.