Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
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$ 80000 - 130000
1 Vacancy
Job Description
The Advanced Surgical Principal Regulatory Affairs Specialist provides regulatory input for new product and sustaining engineering project teams developing a regulatory strategy for global commercialization of products. The specialist should be capable of identifying both domestic and international regulatory requirements early in product life cycles and coordinating the product registrations to meet company milestones and initiatives.
Key Duties and Responsibilities:
- Represent the Regulatory organization on cross functional teams to develop and implement regulatory strategies and carry out associated team output responsibilities.
- Prepare global regulatory files/submissions for product registration as assigned.
- Review and approve proposed design changes and ECOs to assess regulatory impact.
- Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
- Provide regulatory support for ongoing global product registrations as assigned.
- Provide timely review and approval of product labeling for regulatory compliance.
- Participate in all activities associated with product recalls (regulatory agency communications customer communications status reports).
- Establish and maintain product recall files.
- May interface with other ConMed business units/affiliates/distributors as assigned.
- Perform other related duties and special projects as required by management.
This will be a hybrid role 50 onsite in Denver 50 remote
Minimum Requirements:
- Bachelors Degree in science engineering or related field
- 5 years experience years in a regulatory quality or similar position.
Preferred Requirements:
- M.S. in a technical field or MBA preferred
- Additional Regulatory certifications preferred
- Experience within the Medical Device industry preferred
Other Attributes:
- Ability to execute assignments independently as assigned.
- Must possess strong organization skills.
- Must possess strong written and verbal communication skills.
- Demonstrated ability to handle multiple priorities simultaneously.
- US/EU submission experience including authoring and receiving approvals and interaction with regulated bodies (FDA Notified Body etc..
Physical Requirements:
- Must be able to sit/stand for 8 hours
Disclosure as required by applicablelaw the annual salary range for this position is $80000 $130000. The actual compensation may vary based on geographic location work experience education and skill level. The salary range is CONMEDs good faith belief at the time of this posting.
Coloradoresidents: In any materials you submit you may redact or remove age identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical dental vision and prescription coverage
- Short & long term disability plus life insurance cost paid fully by CONMED
- Retirement Savings Plan 401K) CONMED matches your contributions dollar for dollar with the potential for up to 7 per pay period
- Employee Stock Purchase Plan allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us atoption #5.
Required Experience:
Staff IC
Employment Type
Full-Time
