Regulatory Affairs Manager (#2829)

POSITION SUMMARY:

The Regulatory Affairs Manager is responsible for leading the regulatory activities and initiatives at the company. Actively contributes to the development and implementation of regulatory strategies in a rapidly expanding business.

RESPONSIBILITIES:

• Managing the day-to-day regulatory activities and projects, ensuring regulatory compliance and company’s goals.
• Responsible for planning and monitoring of the regulatory budget.
• Support external audits, e.g., ISO 13485, FDA inspections, etc.
• Review and approve regulatory assessments and strategies for projects (R&D, Quality, Operations, Engineering, Distribution, etc.).
• Support, review and approve design and development procedures and records.
• Provide the expertise for all applicable regulations (MDSAP, FDA, CE(EUMDR), ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
• Prepare, write and obtain 510k submissions, Health Canada, EU. Review and approve all regulatory documents submitted to regulatory authorities.
• Reviews sales and marketing materials for regulatory compliance.
• Review and approve all regulatory aspects related to the company’s distributors.
• Maintains regulatory product files to support compliance with regulatory requirements.
• Working with regulatory consultants when applicable.
• Additional responsibilities and projects as assigned in support of business objectives.

EDUCATION AND EXPERIENCE

• At least 5 years of work experience in the medical device industry in a Regulatory role.
• Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
• Experience with US and Canada, European is preferred but not essential.
• In-depth knowledge of the following: ISO 13485, ISO 14971, EU Directives and CFR 21 Part 820.
• Must be flexible with work schedule to work with offshore management and business needs required.
• Previous experience with ISO 13485, CE MDD/MDR certification process required.
• Previous experience with US and international medical device regulations required.
• Proven experience with 510k submissions and clearances, for class II devices.
• Strong FDA Experience.
• Tissue Bank Licensing experience.
• Work across business departments to assist with offshore needs as a guide and contributor.

OTHER SKILLS AND ABILITIES

• Experience in medical devices class IIb (CE), class II (US).
• Experience in Dental implants- Advantage.
• Excellent verbal and written communication skills.
• Detail-oriented with the ability to prioritize efficiently and multi-task.
• Ability to adapt to new challenges, learn quickly, and take action while engaging in a fast-paced, growing environment.

-Some Travel is Required-

It is impossible to list every requirement for, or responsibility of any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description.  The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

It is the policy of the company to attract and retain the best qualified employees. We are committed to providing employment opportunities to the most qualified internal or external candidate based on work-related factors and without regard to non-work-related factors including race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, or veteran status as a special disabled veteran, Vietnam Era Veteran, or other qualifying veteran.

The Company offers competitive salaries, advancement opportunities, and a full range of benefits, including paid vacation, 401(k), medical, dental, and vision.

Equal Opportunity Employer and Affirmative Action Employer M/F/D/V.